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@ 2002 - 2013 ASQ

5/8/13

Job Title: QA Validation Analyst

Company: Biologics, BioPharma

Location: Syracuse, New York

PRINCIPLE OBJECTIVE OF POSITION: Responsible for the validated state of the equipment, instruments and automation in manufacturing facilities. Ensures that all Regulatory and cGMP compliance items are satisfied.

MAJOR DUTIES AND RESPONSIBILITIES:

1. Will have and provide quality oversight on the validation of equipment, instruments and automation in the manufacturing facility. Will have and provide quality oversight on the validation of process utilities. Will have and provide quality oversight on computer system validation.

2. Quality Approver on installation qualification, operational qualification and performance qualification protocols and reports for equipment, instruments and automation in manufacturing facility.

3. Quality Approver on process characterization and qualification protocols and reports.

4. Demonstrates track record of developing and implementing logical and optimal plans to achieve objectives. Develops practical solutions to significant challenges.

5. Provides credible output with little or no direct supervision. Able to identify opportunities for realistic improvements within project scope.

6. Significantly leads or contributes to the creation of team based, collaborative environment promoting candor and receptivity, clarity of purpose and goals, and high commitment to achieve business goals.

7. Develop and communicates expertise in areas beneficial to group/project focus area.

8. Identifies issues within and outside area of responsibility. Evaluates options and presents solutions to manager. Leads cross functional efforts to implement solutions.

9. Will be expected to cross train and develop their expertise in other areas of validation, such as analytical instruments, method validation, etc.

Qualifications:

Education: Bachelor of Science in Microbiology, Biotechnology, Chemical Engineering or scientific field with 8+ years experience in pharmaceutical manufacturing of biologics or aseptic filled products. (or a MS with 5-7 years relevant experience).

Experience/Knowledge Desired:

1. Personnel must have extensive knowledge and experience in Computer Systems validation and validation of automated process control systems (DCS and PLC).

2. Personnel should have extensive knowledge and experience of any of the following is required: operation and validation of processing equipment, operation of process utilities (WFI, HVAC, steam air) and process knowledge of mammalian cell growth, chromatography and filtration of proteins and aseptic processing.

3. Must have effective verbal and written communication skills.

4. Must demonstrate multitasking and organizational skills.

5. Must be able to interact and lead effectively in a team based environment.

6. Attention to written detail is essential.

All inquiries are kept strictly confidential.

Contact: Steven Karski, Alchemy Scientific, Inc., 335 South Biscayne Blvd. 24th Floor,Miami, FL 33131, 786-347-6300, skarski@alchemyscientific.com

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2/25/13

Job Title: Head of Quality – OTC Consumer Products Company (FDA regulated)

Location: New Jersey
Primary Functions: The Head of Quality Assurance is responsible for evaluating all aspects of product quality and making recommendations on improvement. S/He will act as the liaison with RIAG & 3rd Party Organizations (Packaging, Warehousing, etc) on Quality Assurance and Control as well as key influencer on Regulatory Affairs and Compliance.
Essential Duties:
1. Quality Assurance – manage all issues from day-to-day product sample reviews to investigations, documentation and recommendations on recalls.
2. Quality Control – contract for and interpret data on any laboratory analysis required in house or through contract labs.
3. Regulatory Compliance – conduct audits of RIAG manufacturing, 3rd party packaging location and warehouse to ensure compliance. Make recommendations on changes and support implementation including but not limited to cGMP training, writing & issuing SOP’s, statistical analysis and support of adverse reaction and consumer complaint communication.
4. Regulatory Affairs – act as key point of contact with FDA counsel for ingredient registration, label and claim/copy approval. Keep current on FDA requirements and make recommendations to Marketing and Management on changes. This will include tracking and reporting hours used versus budget.
5. Performs all required Quality Assurance issues as required by the FDA.
Other Duties:
6. Prepare reports or projections as requested.
7. Occasional out of town travel domestically and internationally for audits and meetings.
8. Other duties as may be assigned.
Required Education & Experience:
Bachelor’s Degree in relevant field is required.
Minimum of five years’ experience in a variety of Quality Assurance/Control and/or Regulatory Affairs/Compliance roles for a consumer products or OTC drug company.
Required Licenses, Certificates Or Knowledge
Microsoft Word, Excel, and Outlook. Knowledge of FDA OTC drug monograph is preferred
Contact: Steven Karski, Alchemy Scientific, Inc., 335 South Biscayne Blvd., 24th Floor, Miami, FL 33131, 786-347-6300, skarski@alchemyscientific.com      

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3/12/13

Job Title: Senior Regulatory Affairs Associate

Location: Mahwah, NJ

Company Profile:  Mindray North America manufactures products found throughout the hospital, and are largely focused in the areas of anesthesia, emergency medicine and critical care. Medical facilities that count on our products can be found in over 80 countries across the world. We have direct sales and service organizations in the U.S., U.K., France, Germany, Italy, Belgium and the Netherlands. Our international distribution network extends our reach to Central and Latin America, Europe, Middle East, Africa, Asia Pacific, Australia and Canada.

Job Description: Prepare domestic and international regulatory submissions. Assist in the implementation of product field corrections and product removals (recalls. Provide routine regulatory support to all functional areas, including project teams/new product development. Prepare /coordinate the international registrations

-Preparation/coordinate the compilation of 510(k)s/EU Technical Files

-Assist with the implementation of product field corrections and product Removals from initiation through completion, e.g., generate documentation required per the divisional policy (customer and regulatory agency notifications, provide status reports to regulatory agencies, as necessary and provide close-out reports to applicable regulatory agencies).

-Assist in the execution of clinical studies, user preference studies and focus groups.

-Provide routine regulatory support to the developement staff as required, including participation on project teams, and the review of product labeling or promotional/advertising materials.

Requirements:

• Bachelors Degree / science, engineering or similar technical field preferred

• Minimum of 3-5 years regulatory experience

• In-depth knowledge of FDA and international medical device regulations preferred

• Excellent organizational, analytical and writing skills are required

• Good interpersonal communication skills are necessary

• Good computer skills (word processing, spreadsheet, etc.) are necessary

Contact: If interested, please send resume to M.Grieco@Mindray.com

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3/19/13

Job Title: Senior Quality Engineer

Job Location: Plainview, NY

Company Profile:  Veeco Instruments Inc. delivers leading process equipment solutions that drive tomorrow’s technology breakthroughs today. We help our customers — manufacturers of high-brightness light-emitting diodes (LEDs), solar panels, hard disk drives, semiconductor chips, wireless devices and more — to make a more productive, cleaner and sustainable environment, and enable discoveries and products that will change our lives. Veeco is a dynamic, innovative and high-growth company recognized as the best in the markets we serve.

Job Description:  Veeco is looking for a Senior Quality Engineer to drive quality improvements in supplier performance, manufacturing and customer satisfaction in an outsourced, lean manufacturing model. This is an opportunity to work closely with senior management to have significant impact on the design and delivery of quality initiatives and oversight. If you are a self-starter with strong communication skills, are motivated by the challenges of a growing business in a high tech industry, and are extremely effective in driving corrective and preventative actions, then this may be the job for you.

Responsibilities:

• Enable a Quality Program that drives improvement across multiple business functions including Operations, Engineering, R&D and Technical Service. The Sr. Quality Engineer will deliver quality reviews, tools and processes for gathering, processing and evaluating data and metrics while leading and supporting improvement teams for Plainview and Camarillo Operations.
• Minimize variation in quality business processes through development and training of Standard Operating Procedures and Work Instructions designed to reduce variability and improve quality for Veeco’s customers
• Partner with contract manufacturing and supplier partners to improve their quality performance resulting in improved operational results, reduced costs of poor quality, and reduced risk of quality excursions
• Identify and drive continuous improvement to key processes as measured through performance metrics such as out-of-box quality and other operational and quality performance metrics leading to improved customer satisfaction with reduced cost of poor quality
• Lead Root Cause Corrective Action teams, utilizing the 8D process to ensure that corrective actions are effectively identified and driven to closure and that the learning from 8D’s is effectively propagated to maximize the value of the 8D and to eliminate risk of recurrence.
• Participate in cross-functional teams conducting supplier selection while also driving continuous improvement of quality with Veeco’s current suppliers
• Support change control processes through effective planning, qualification and communications (internal and external) designed to mitigate risk to Veeco and its customers
• Support systemic continuous improvement of both product quality and systems quality, leveraging best practices to enable Veeco to achieve the highest quality and customer satisfaction in its products and services
• Lead ISO initiatives from corporate driven standards to local implementation
• Support intra-division quality improvement initiatives
• Plan, design and deploy quality assurance initiatives
• Drive failure analysis and associated communications where quality issues have impacted the customer

Qualifications:

• Bachelor's Degree in Engineering.
• 8+ years of experience as a quality engineer or quality manager supporting the manufacturing operations of tools/components utilized in high technology manufacturing.
• ASQ Quality Engineer and auditor certification, along with six sigma black belt certification is highly preferred
• Travel both domestic and international (10% target)

Knowledge, Skills, & Abilities:

• Relationship management expertise; History of positively partnering with internal operations, key suppliers and critical contract manufacturing partners, together partnered to execute on time and on target to deliverables.
• Comfortable working in a matrix environment executing against business unit demands while delivering to corporate objectives.
• Initiative, superior problem solving skills, results oriented, good decision maker, excellent analytically, extremely well organized, assertive, and a team player with situational sensibility
• A history of effectively implementing root cause corrective actions
• Practical experience in Statistical Process Control
• Experience in driving initiatives such as ISO 9001:2008, LEAN, Six sigma, 5S, and TQM is a plus
• Experience supporting new product development processes with a quality and reliability engineering skill set also highly desired

Interested in learning more? Please contact:  Brenden Wright, (410) 984-2610, brendenwright@gmail.com

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4/4/13

Job Title: Process Management Consultant

About the Employer and the Job: Major Oak Consulting, a Management Consulting firm headquartered in New Jersey, is built on a foundation of integrity and doing what is best for the client. We deliver world class strategy, process transformation, change management, performance management and project/program management services to clients ranging from Fortune 100 to emerging growth organizations.

We are currently seeking professionals with 8-10+ years overall experience and 5+ years of relevant process optimization and management experience for work on dynamic client engagements. The applicant should be creative and have strong interpersonal, analytical, and problem-solving skills. Ideal candidates should have relevant Process Management experience in IT, HR, finance, call center or other similar areas with superior oral and written communication skills, a client service focus, a willingness to travel to meet client demands, as well as an ability to define problems and implement a complex solution in a fast paced environment.

Our Culture: We are a close family of consultants with incredible work ethic, professional standards, and similar values, where personal touches and individual considerations are highly valued. We take pride in our warm, supportive, and collaborative environment – one based on mutual respect, idea sharing, professional candor, and a true passion for helping clients improve business performance. Not only is our team is one that shares knowledge, experience and practices all in order to deliver the highest quality of service to our clients, but we enjoy each other’s company and, as a relatively small firm, take the time to get to know each other at work, and outside of work.

Finally, we believe that placing a high value on a balanced life for our consultants is essential in maintaining the energy, drive, and enthusiasm to deliver great results and allows us to attract and keep the most talented people.

Responsibilities:

• Organizing, leading and facilitating potential cross-entity, enterprise wide redesign initiatives that will encompass an end-to-end analysis and future state redesign that requires specialized knowledge or skill critical to the re-design effort
• Developing root cause analysis and business case for proposed technology, staff and structure changes, including cost estimates
• Facilitating groups in mapping processes
• Identifying best practices for process re-design, improvement, and implementation
• Applying Six Sigma tools and techniques to client situations and processes
• Establishing standards for measuring performance against process requirements
• Ensuring projects align to management strategy
• Developing metrics that provide data for Process Management indicators for future improvement opportunities
• Identifying and managing resources, including cross-entity members, to successfully execute projects
• Providing consultation on the use of re-engineering techniques to improve process performance and product quality
• Coaching multiple redesign teams in Six Sigma process and tools
• Driving business awareness of quality/process methodology
• Assessing risk and developing mitigation strategies
• Championing change and effectively managing the implementation of new ideas
• Developing communications for stakeholders at all levels to ensure knowledge, buy-in and support of redesign activities

Professional Qualifications - Demonstrated Knowledge & Skills:

• Process reengineering and optimization expertise
• Performance management expertise
• Advanced analytical problem solving skills
• Strong conceptual thinking ability
• Attention to detail and perseverance to completion
• Strong organization/time management skills
• Strong relationship building between internal customers, vendors and employees
• Strong interpersonal and communication skills – ability to interact with all levels
• Ability to deal constructively with change
• Impeccable relationship management
• Detailed process and financial analysis and modeling a plus
• Advanced level Microsoft Project, PowerPoint, Visio, Excel skills

Education and Certifications:

• College Degree required
• M.S., M.A., or M.B.A graduate level degree preferred
• Six Sigma, or similar process improvement training/certification preferred
• Project Management Training/Certification such as PMI’s Project Management Professional (PMP) preferred

Minimum Experience:

• 8-10 years of work experience
• 5+ years of relevant Process Management experience
• External consulting experience required
• Program Management experience preferred
• Change Management experience preferred
• Organizational development experience preferred

We are seeking candidates interested in full time positions with Major Oak, as well as project-based positions. Candidates must be willing to travel to client sites on a regular basis. Compensation and benefits are commensurate with experience and qualifications. If you are interested in this position, please attach a current resume, your most recent compensation, your willingness to travel and current availability.

To learn more about Major Oak Consulting, visit our web site at www.majoroakconsulting.com.

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4/6/13

Job Title: Director – Biologics Manufacturing

Company: Biotech/BioPharma

Location: Syracuse, New York

Job Description: The Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process). The Director, Biologics Manufacturing is responsible for all components of the manufacturing operations organization, which include: Cell Culture and Purification. Drives resources to address priorities, meet production schedules, maximize productivity, reduce costs, and increase efficiencies through continuous improvement strategies. Develops and leads a high performance management team responsible for commercial manufacturing, directs the recruitment and development of manufacturing staff. Invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition. Establishes and communicates business objectives for manufacturing, consistent with company biologics strategy. Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time. Sets high standards for compliance to meet and exceed regulatory agency requirements related to biologics manufacture and assure compliance with directives including safety, training, cGMP, quality systems documentation, change control, operational variance, and failure investigation. Develops annual operating budget/staffing levels and manages operation to achieve the financial objectives. Participates actively on the site Senior Leadership Team to establish site mission, annual goals and desired culture while undertaking supportive actions which build commitment to these values, objectives and sustained site-wide teamwork.

Qualifications: A Ph.D. or M.S. in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline. A minimum of 8-15 years of successful managerial experience in cGMP biologics manufacturing with a documented history of technical accomplishments. An in depth knowledge of regulatory requirements for filing biologics in the US and Europe. Knowledge related to mammalian cell bank, cell culture and purification manufacturing as well as in depth knowledge of validation for a biologic manufacturing facility. Demonstrated success as a strong team leader who uses past management and supervisory experience to develop departmental staff through effective feedback and coaching. Proficiency in developing and managing departmental budgets. Excellent organizational skills and the ability to successfully manage multiple technical projects and priorities, excellent analytical and strategic thinking skills and experiences with Lean Six Sigma tools. Direct experience with supporting 24/7 manufacturing operations is preferred.

All inquiries are kept strictly confidential.

Contact: Steven Karski, Alchemy Scientific, Inc., 786-347-6300, skarski@alchemyscientific.com

Feel free to connect with me on LinkedIn!

http://www.linkedin.com/pub/steven-karski/0/874/472

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4/10/13

Job Title: Manager of Consulting Services

About the Employer and the Job: Major Oak Consulting, a Management Consulting firm headquartered in New Jersey, is built on a foundation of integrity and doing what is best for the client. We deliver world class strategy, process transformation, change management, performance management and project/program management services to clients ranging from Fortune 100 to emerging growth organizations.

We are currently seeking candidates with 7+ years of management consulting experience for work on dynamic client projects and internal firm initiatives.  The applicant should be creative and have strong interpersonal, analytical, and problem-solving skills.  Ideal candidates have process improvement, organizational change management and project management experience combined with superior oral and written communication skills, a client service focus and the ability to identify opportunities for improvement, develop recommendations and implement complex solutions in a fast paced environment.  This position requires limited travel (25% or less) and would be a good fit for an experienced consultant who is looking to settle down and wants less travel.
Responsibilities: This role’s primary responsibility is to develop the consulting delivery organization by focusing on Quality Assurance, Talent Management, and Practice/Methodology.  Core functions include:

• Performs Quality Assurance role concerning consulting deliverables on 2-4 projects at a time in a billable capacity
• Partners with Recruiting Lead to identify needs and staff projects efficiently and effectively, including working with the Leadership Team to facilitate alignment of QA resources
• Oversees the Talent Management process for consulting services
• Works with administrative managers to ensure timely and meaningful performance reviews and objective setting
• Researches and organizes training/development opportunities at the team and individual levels
• Works with administrative managers to facilitate the onboarding process for new employees and contractors
• Oversees engagement closeout process to ensure all closeout checklist items are completed in a timely manner
• Manages down resources effectively by utilizing them on internal projects and/or business development activity
• Owns SharePoint Administration as a repository for talent management and consulting methodologies
• Provides regular proactive outreach to temp employees and contractors who are not covered by other administrative reporting and mentoring relationships
• Development Designing and performing QA function for process improvement initiatives.  
• Providing project management and program level support to clients
• Assessing organizational issues and risks and developing mitigation strategies and solutions
• Identifying project risks developing recommendations and implementing effective and proactive risk mitigation solutions
• Coordinating project work by partnering with clients to assign activities and monitoring progress
• Facilitating group conversations and meetings, including scheduling, developing agendas and capturing meeting minutes/follow-up items
• Developing and facilitating implementation of organizational strategy and design
• Championing organizational change and participating in the implementation of new ideas

Professional Qualifications - Demonstrated Knowledge & Skills:

• Business process improvement experience
• Project Management experience
• Analytical problem solving skills
• Proven expertise managing teams of consultants
• Organizational Change Management skills including change management planning and execution
• Strong conceptual thinking ability
• Attention to detail and perseverance to completion
• Strong organization/time management skills
• Strong interpersonal and communication skills - ability to interact with all levels
• Able to deal constructively with change
• Impeccable relationship management
• Lean/Six Sigma knowledge and experience a plus
• Effective facilitation of group discussion
• Advanced level Microsoft Project, PowerPoint, Visio and Excel skills

Education and Certifications:

• College Degree required
• M.S., M.A., or M.B.A graduate level degree a plus
• Project Management Training/Certification such as PMI’s Project Management Professional (PMP) a plus
• Six Sigma, or similar process improvement training/certification, a plus

Minimum Experience:

• 7+  years of consulting experience
• 4-5+ years consulting team management experience
• Process Improvement experience
• Change management experience
• Project management experience
• Program management experience a plus
• Performance management experience a plus

Salary: 120k – 150k per year including a comprehensive benefit package.  Salary will be commensurate with candidate’s skill and experience within this range
We are seeking candidates interested in full time positions with Major Oak in the New York/New Jersey area.  While most of our work is in the NY/NJ area, must be willing to travel to client locations periodically as needed.  If you are interested in this position, please attach a current resume, your most recent compensation, and current availability.

To learn more about Major Oak Consulting, visit our web site at www.majoroakconsulting.com.

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5/8/13

Job Title: Director – Manufacturing Operations, Tech Transfer/Mfg. Biologics Prominent

Company: BioPharma

Location: Syracuse, NY

Position Description: This position will be the lead for the Subject Matter Expert department within the Biologics External Manufacturing group. The individual will provide direction to cell culture scientists, microbiologists, purification, and analytical chemists. They will be responsible for developing the scientific talent essential to drive performance from the early phases of technical transfer to routine commercial manufacturing. This is a critical function that interfaces with project managers to assign resources in the support of company biologic drug substance produced at third parties. The individual will also facilitate alignment of goals and objectives with internal and external cross-functional teams that support the manufacturing of biotherapeutics. The Biologics External Manufacturing group is engaged in a 3 year initiative to achieve Best In Class performance. The successful candidate will be responsible, and provide leadership, for significant elements of this initiative.

Qualifications: Candidates should have a PhD or MS in cell culture, protein chemistry, bioanalytical chemistry, biochemical engineering or other related disciplines with 10-15 years of experience.  Experience in process development, technical transfers, support of cGMP manufacturing and technical trouble shooting, and interfacing with health authorities on CMC filings and audits is required. In addition, candidates should have a demonstrated performance in leading multi-discipline teams to accomplish significant technical milestones. They should be facile and enjoy working in a matrix organization. Strong technical writing and verbal communication skills are required.

Contact: Steven Karski, Alchemy Scientific, Inc., 335 South Biscayne Blvd., 24th Floor, Miami, FL 33131, 786-347-6300, skarski@alchemyscientific.com      

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5/8/13

Job Title: Manufacturing Engineer

Company: Medical Device Company

Location: Philadelphia Area, PA
Position Description: The Manufacturing Engineer will develop and sustain the operation of a global supply chain consisting of multiple external business partners related to company products and services. The incumbent will oversee the manufacturing process development and validation of medical electro-mechanical devices. The position will manage resolution of manufacturing/technical issues as they arise in the course of product development and sustaining engineering. This position will also be responsible for developing and overseeing supply chain performance standards for global supply chain metrics.
Contact: Steven Karski, Alchemy Scientific, Inc., 335 South Biscayne Blvd. 24th Floor,Miami, FL 33131, 786-347-6300, skarski@alchemyscientific.com
 

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5/8/13

Job Title: Senior Mechanical Engineer

Company: Medical Device Company

Location: Boston Area, MA

Position Description: As a Senior Mechanical Engineer, the successful candidate will collaborate with research scientists and a cross-functional engineering team for the development of a new generation non-invasive continuous glucose monitoring system. He or she will conceive, design, and bring into production products that define the industry. As a key member of Product Development technical staff, the Senior Mechanical Engineer is expected to proactively provide innovative technical solutions based on extensive knowledge and experience of Mechanical Engineering specifically around skin interface instruments, electromechanical assemblies, control mechanisms, and materials/processes. Responsibilities will include 3D modeling of design, performing design reviews, generating mechanical design specifications and interfacing with outside design partners. The successful candidate will implement product designs for performance, innovation, reliability, and cost.
Contact: Steven Karski, Alchemy Scientific, Inc., 335 South Biscayne Blvd. 24th Floor,Miami, FL 33131, 786-347-6300, skarski@alchemyscientific.com
 

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5/8/13

Job Title: Director – Manufacturing Sciences & Technology

Company: Prominent BioPharma

Location: Syracuse, NY

Position Description: The leader of Manufacturing Sciences & Technology is responsible for scientific and technical oversight of Biologics manufacturing processes from full scale process validation through commercialization and life cycle management within the manufacturing facility. Support to the external network of biologics drug substance manufacturers will be required as well. This position reports to the Executive Director, Biologics Manufacturing Sciences and Technology, within the Biologics Development and Manufacturing Department of Global Manufacturing and Supply Division. The main responsibility of the Director of MS&T is to provide robust and timely technical support to biological products manufactured at the site, in close collaboration with the leaders in Manufacturing, Manufacturing Technology, and Quality at the site. The Director of MS&T will work in close collaboration with the Associate Director of Process Life Cycle Management and the Process Champions to define the technical agenda for each commercial molecule. He/she has direct responsibility for a team of approximately 10 PhD and 15-20 MS/BS scientists and engineers supporting the biologics products manufactured at the site and at 3rd party, working in a matrix mgmt with the PLCM group.  Lead three groups located at MS&T site: Upstream, Downstream, and Materials Sciences supporting commercial products manufactured at site. In collaboration with Biologics Process Development, responsible for large scale technical transfer activities for phase 2b/3 clinical studies and to establish process control strategies and specification windows for manufacturing during commercialization at scale; assures that clinical batches are representative of process capabilities. Accountable for process validation at scale from writing protocols through execution for biologics drug substance manufactured in. Accountable for CMC authoring activities for BDS manufacturing. Identify and implement commercial process and life cycle improvements. Assure manufacturing operations are aligned with the registered process. Provide support for technical investigations and change controls. Define relevant operational/technical standards and practices for the site. Define raw material and consumable specifications and standards for the site. Establish platform for freeze/ thaw and storage conditions for biologics drug substance manufactured at the site; responsibilities for validation activities for drug substance storage containers, freezing, thawing and shipping.
Qualifications: Desired PhD in Life Sciences, Biochemical Engineering (or other relevant discipline) with a minimum of 10 years of experience in biotechnology processes at manufacturing scale for protein therapeutics. The preferred candidate will have experience in a cGMP regulated environment, preferably gained through direct support of biologics commercial manufacturing. Experience in both large scale production of biologics using mammalian cell culture, and downstream processing for recombinant therapeutic proteins. Experience leading Materials Science function in a manufacturing support role also desirable. Detailed knowledge of ICH guidelines, a thorough knowledge of statistical process tools, experienced in experimental design and a sound understanding of process validation. Requires excellent problem solving skills, and experience leading and managing groups of at least 15 PhD/MS/BS Scientists and Engineers and cross-functional project teams.
Contact: Steven Karski, Alchemy Scientific, Inc., 335 South Biscayne Blvd., 24th Floor, Miami, FL 33131, 786-347-6300, skarski@alchemyscientific.com      

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5/17/13

Job Title: Quality Engineer

Job Location: Freehold, NJ or Danbury, CT
Job Purpose: Quality Engineer to maintain ISO/TS 16949 Program and provide support for current and future growth initiatives - OE/OES and aftermarket business.  Assist Quality Manager in maintaining the Prestone Quality Management System (Specifications) and support continuous improvement initiatives at Prestone manufacturing plants and contract packager locations.

Position Responsibilities:

1. Maintain TS-16949 Program which include the following:

A. Conduct TS Internal Audits of the manufacturing plants and Corporate PTC.

B. Conduct quarterly QPT meetings

C. Maintain registrar contract documentations and audit set-up

D. Maintain all applicable reporting requirements (annual Ford Q1 assessments and MMOG/LE assessments)

E. Review plant quality performance for Ford and GM via the Covisint system and internal analytical testing

F. Maintain Covisint System

G. Maintain Toyota Quality Program

H. Create/revise Quality System specifications including (FMEA’s, Control Plans, Gauge R&R)

I. Support OE/OES global growth initiative (qualifications, documentation and reporting requirements)

J. Support OE/OES Heavy Duty growth initiatives (qualifications, documentation and reporting requirements)  

2. Support/assist Quality Manager with Quality Specifications (creation, revision, inputting into PDM specification system)

3. Support/assist Quality Manager with SDS/Hazox entry

4. Support /assist Prestone Manufacturing Plants on continuous improvement process/AIP initiatives (cost down projects, new product introductions, continuous improvement projects, addressing quality concerns etc.)

5. Support /assist Contract Manufacturers to drive continuous improvement (cost down projects, new product introductions, continuous improvement projects, addressing quality concerns etc.)

6. Support /assist Prestone Suppliers to drive continuous improvement (cost down projects, new product introductions, continuous improvement projects, addressing quality concerns etc.)

7. Work closely with Prestone Technology Center, Packaging and plant operations regarding product development and product launches  

8. Constantly look for ways to improve current processes in order to deliver exceptional quality including leading and/or participating various projects

9. Comply with all PTC EHS requirements

Requirements:

- Bachelor’s Degree in an Engineering discipline (ChemE, ME, IE)

- 2-5 years’ experience   

- ISO/TS 16949 experience a plus

- Internal Auditing a plus

-Quality Core Tools (PPAP, FMEA, MSA, SPC) a plus  

1. Good organizational, verbal, written communication, and listening skills.  Ability to accurately communicate complex information to a wide variety of people.
2. Excellent computer skills,( Microsoft Office Access, Outlook, Word, Excel).

-Willing to travel as needed

Key Challenges:  

- Successfully maintain the ISO/TS 16949 program/certification.

- Working with manufacturing plants (internal and CM’s) to ensure a strong Quality Management System

Contact: Stuart Zweighaft, UCI-FRAM Group, Recruiting Manager, T - 847-482-4047, E - stuart.zweighaft@framgrp.com  -  www.uci-fram.com

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