QA Manager Jobs in New Jersey

Job Title: Quality Assurance Director Company: Novel\/Nutratech Location: West Caldwell, NJ Description: Rapidly growing North Jersery dietary supplement processor seeking candidate with a B.S. in chemistry or food science at a minimum.  Individual will be required to write, review and train employees on evolving GMP's and SOP's. Attention to detail, ability to execute and complete tasks on time and hourly/daily sense of urgency a must.  5+ years experience.  Excellent salary and benefits commensurate with ability and experience.  Please email your resume with salary request.

Job Title: QA Manager / Quality Assurance Manager - Pharmaceutical API a must Company: HireSource Solutions Location: Gibbstown, NJ Description: QA Manager - API expereince desiredPlease do NOT apply if you are not local - no relocation assistance provided - local candidates onlyMust be a US Citizen or Green Card Holder - Client will NOT sponsorTo be considered for this role, you MUST have prior Pharmaceutical experience and or experience in a FDA regulated environment.API expereince is a MAJOR plus.QA MANAGER    SUMMARY OF POSITIONThe Quality Assurance group will report through the Manager to the Director.  The Manager shall be responsible for GMP compliance in the facility on a day-to-day basis.  The incumbent will work to make improvements in regards to GMP standards, leading and implementing new initiatives.  The incumbent will coordinate all customer audits, preparing the response and monitoring the implementation of corrective actions. The incumbent will be the point person on FDA audits, assisting the Director with strategy and response.  The incumbent will cross-train to support other functions within Quality Assurance Compliance and Regulatory areas. The incumbent will assist fellow employees with compliance issues.   The QA Manager will manage the day-to-day affairs of FDA audits, supervising the retrieval of documents and preparing any required response.  The incumbent will explain company position on any issues discussed with the agency.  The incumbent will write and revise Standard Operating Procedures, as required and independently prepare or alter SOPs that S/he finds are needed.  The incumbent should have a working knowledge of how electronic record keeping affects the pharmaceutical industry, and become familiar with the Company’s involvement with electronic records (21 CFR Part 11). S/he must have a working knowledge of all SOPs, CGMPs, and Company Regulations that directly affect the position, and a firm familiarity with all others procedures that affect the Company as a whole and that affect the pharmaceutical industry.  BACKGROUND Bachelor’s in Chemistry with a minimum of 10 years’ experience in the pharmaceutical industry; or a Master’s in Chemistry with a minimum of 8 years experience in the pharmaceutical industry.  Ph.D. in chemistry with at least 5 years experience in the industry.  Degrees in related technical disciplines are acceptable.  At least seven year’s experience in a job in an FDA regulated environment.  API experience strongly preferred. Excellent communication skills, particularly technical writing skills, are mandatory.  Organic chemistry knowledge required.  Knowledge and previous experience with CGMP and 21 CFR Part 11 required.  Experience with DMF filings also required. If you are qualified: Please forward your resume in WORD. Please include your salary requirements.  Your resume will be held with strict confidence and will NEVER be forwarded to any of our clients without your permission. If you are NOT interested or unqualified, please send us a referral. This is an immediate and urgent need for our valued client and therefore, we are offering a $1000 refer-a-friend fee to anyone who leads us to a candidate who is hired for this position.Word .doc formatted resumes and salary requirements to:  Mike IredaleHireSource Solutions Register to View -source.com  www.hire-source.com MORE JOBS?? http://www.hire-source.com/listings.html  HireSource recruiters are dedicated to working with the finest technical professionals throughout the country. We know the market. We know the hiring managers. We have the knowledge, resources, and contacts to make your search more complete and efficient. Whether you are looking for more opportunity, a shorter commute, better benefits, or a higher salary, we’re the best chance there is to uncovering that position you never even knew was available.

Job Title: Head of QA/ Sr. QA Manager Company: Design Strategy Corporation Location: Jersey City, NJ Description: Our direct client is in need of a Sr. QA Manager / Head of QA to lead their Quality Assurance Group within clients of Fixed Income/Derivatives Technology group. The successful candidate must be able to work independently while actively participating in a global team. This role will provide the candidate selected with a tremendous amount of diversity, personal and professional growth. FI/Derivatives Technology Group is in the beginning stages of a major multi-year project to develop, enhance and support our new strategic platform for fixed income and derivative products. Client's new high performance system will use distributed computing technologies to deliver a platform capable of sub-millisecond matching at very high sustained loads while achieving five nines availability. Quality Assurance is a crucial part of this effort and an area of major investment to improve the automation, scale and quality of testing. The successful candidate will lead and manage a team of approximately 8-10 onshore testers, engineers and test leads responsible for the functional and regression testing of their application software, assuring software releases of the highest possible quality onto their platforms. In addition to the onshore team a newly established offshore team is helping to increase automation and the scale of execution. Client will be making significant investments in test tools and test script automation that will provide us with enhanced capabilities in responding to the needs of the business. Suitable candidates will need to demonstrate a track record in leading comparable Quality Assurance groups within the financial services arena.

Job Title: Quality Assurance Manager Company: Omni Resources, Inc. Location: Princeton, NJ Description: Omni Resources, Inc., an Information Technology Consulting Firm located in Eagan, Minnesota is currently seeking a Quality Assurance Manager. This position is located in Princeton, NJ. This is a 6 month contract position with the potential to go longer. This contract is scheduled to start as soon as possible.**Client requires citizen or green card**Job Description:The Quality Assurance Manager is responsible for creating and implementing quality assurance programs. Ensures adequate product tests have been conducted by the Quality Assurance Analysts and analyzes results. Responsible for administering the required problem management processes and providing problem status updates to ensure implementation timelines will be met. Provides recommendations to continuously improve quality assurance requirements with the QA programs, as well as recommendations on software acquisitions to improve information systems efficiency. The Advanced Quality Assurance Lead may have accountability for managing the work efforts and output of 1-2 QA Analysts or a small team and 1-5 intermediate projects.Responsibilities:* Work with QA Analysts and Developers to ensure that all aspects of the system have proper testing coverage and overall system reliability, performance and quality* Comply with the system development life cycle (SDLC) and project management methodology (PMLC) by participating in scope assessment, risk and cost analysis* May coach, lead and mentor other team members* Provide testing management for ongoing projects and future initiatives* Deliver effective and efficient testing solutions by meeting key project milestones and overall project deliverables on time, and adhering to development and quality standards* Analyze the testing needs and develop testing strategy and plans* Review and approve test plans, scenarios, scripts or procedures such as database impacts, software scenarios or usability.* Review software documentation to ensure technical accuracy, compliance or completeness and/or to mitigate risks* Ensure application documentation is complete and maintained/ updated in a timely fashion Requirements:* Bachelors degree in Information Technology, Computer Science, Computer Engineering or relevant field* 10+ years experience supporting technology projects* 10+ years leading quality assurance projects/programs* 7+ years of business systems experience* 7+ years experience in systems testing Skills and Competencies* Strong knowledge of testing disciplines and methodologies* Strong documentation skills* Expert knowledge of computer hardware and software* Project management knowledge* People management skills* Analytical thinker, detailed oriented* Interpersonal skills* Good problem solving skills* Ability to drive results and mentor and provide constructive feedback* Ability to work independently* Organized with good time management skills* Lead, coach and influence others for results and good performance If this is position is interesting to you or someone you know please send back MS word resume to Register to View Resources, Inc. is an IT consulting firm with 26 years in the industry. Our core belief is that strength in technology can only be achieved through the strength of our people. We work with our consultants to provide on-going training opportunities, a pleasant work environment and maintain frequent branch staff contact and support while on assignment.An Employee-Owned CompanyWe invite you to visit our website at www.omniresources.com.Affirmative Action/Equal Opportunity EmployerCELEBRATING 26 YEARS OF EXCELLENCE!

Job Title: Quality Assurance Manager Company: Company Confidential Location: Paterson, NJ Description: About the JobHigh-Graphics Corrugated Box Manufacturer located in Northern New Jersey is seeking a Quality Assurance/Quality Control Manager for its manufacturing facility.  Basic Functions:       This position is responsible for quality control to ensure that all products and materials meet customer requirements and/or specifications.  The Quality Control Manager will inspect and test products at various stages in the production process. He/she will establish testing procedures to determine compliance with customer specifications.  The Manager will also perform testing on incoming raw materials to measure product performance under a variety of conditions. The Quality Control Manager is responsible for the documentation of test results.  The manager will also oversee the company ISO-9001 compliance.Accountabilities and Responsibilities:·         Actively supervise the quality control function and staff.·         Establish, refine, and ensure compliance with quality control procedures to ensure that the product made meets the customer's specifications.·         Ensure that quality requirements and quality policy are adequately defined and distributed and that procedures are in place to support them.·         Maintain appropriate lab testing equipment to perform appropriate testing of produced boxes as well as applicable incoming raw materials.·         Ensure that staff is trained and versed in the use of lab testing equipment.·         Apprise management of internal and external customer quality problems and provide recommendations for improvement with follow-up for results.·         Establish and maintain procedures for timely collection, appropriate analysis of data, and distribution of quality and job performance information.·         Collaborate in the diagnosis and evaluation of manufacturing quality problems with other staff member to determine cause, assign responsibility for corrective action, and report results.·         Develop and implement training programs for quality control staff to ensure understanding of quality objectives and programs.·         Establish an incoming materials inspection process in collaboration with internal customers and inspect incoming material for compliance with pre-determined specifications.·          Establish a relationship with external customers to understand their box requirements and the nuances of their line filling equipment.  Develop and maintain a file of customer requirements.·         Ensure safe working conditions for staff.·         Lead the problem-solving team initiatives to reduce waste and solve quality problems.·         Maintain the company’s quality management system compliant to ISO-9001 requirements.  This function includes control of quality system documents and data control, training, auditing, control of non-conformance and corrective-preventative action.·         Organize and conduct internal quality audits in all departments affected by the ISO-9001 standard.  Provide formal training in the functions of quality systems auditing to key personnel in all departments.·         Ensure that our ISO 9001 standards continuously reflect best business practices. Nature and Scope:    This position covers all operations of the company.  ·         Extensive knowledge of packaging and/or manufacturing industry. ·         Undergraduate degree in related field (preferred). ·         Training in statistical process control and quality techniques.·         Knowledge of MSWord, PowerPoint  and Excel Reporting Relationships:     Other positions reporting to the same superior position: V.P. Sales/COO, CFO and Plant ManagerSubordinates reporting to this position: Quality StaffWork Environment:  Normal office as well as plant environment.Intensive vendor and customer contact.  Frequent customer visits.

Job Title: QA Manager - NJ Company: Dendreon Corporation Location: Morris Plains, NJ Description: Dendreon seeking a highly motivated QA Manager to help build our New Jersey QA team and participate in the preparation of the site for FDA inspection. This is an excellent opportunity for someone to provide leadership in a fast-paced, high-volume production environment with high quality and regulatory standards. Efficiency, accuracy and excellent communication skills are essential to success in this position. General Summary: The QA Manager will provide leadership and support for the development and implementation of Quality Assurance Policies and Procedures. In addition, the Quality Assurance Manager will provide direct support to the NJ Immunotherapy Manufacturing Facility as described below. Hiring and supervision of Quality Assurance staff that covers multiple work shifts.. Review and approval of GMP controlled documents including SOPs. Manages the NJ site Material Review Board. Issues batch records and labeling in support of immunotherapy manufacturing. Provides for batch record review and disposition of immunotherapy products. Performs lot packet review and disposition of raw materials. Ensures initiation, investigation, and closure of lot related deviations, non-conformances, and CAPAs. Provides support for the recall of non-conforming materials, investigations associated with product complaints, and biological product deviation reports. Job Requirements: Bachelor’s degree in a scientific discipline or equivalent. Typically 7 years related experience in cGMP/FDA regulated industry. Typically 3 years leadership experience. Knowledge of cGMP/QSR and FDA device/drug/biologics regulations is required. Proficient in MS Office applications. Experience with ERP and/or MRP systems preferred. Working Conditions and Physical Requirements: May be required to work alternate shifts.Ability to gown aseptically for work in Clean Room environments.Some travel may be required. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: QA Manager - NJ Company: Dendreon Corporation Location: New Brunswick, NJ Description: QA Manager - NJJob Type: Regular Full-TimeLocation: Morris Plains, NJJob Description:Dendreon seeking a highly motivated QA Manager to help build our New Jersey QA team and participate in the preparation of the site for FDA inspection. This is an excellent opportunity for someone to provide leadership in a fast-paced, high-volume production environment with high quality and regulatory standards. Efficiency, accuracy and excellent communication skills are essential to success in this position.General Summary:The QA Manager will provide leadership and support for the development and implementation of Quality Assurance Policies and Procedures. In addition, the Quality Assurance Manager will provide direct support to the NJ Immunotherapy Manufacturing Facility as described below.* Hiring and supervision of Quality Assurance staff that covers multiple work shifts..* Review and approval of GMP controlled documents including SOPs.* Manages the NJ site Material Review Board.* Issues batch records and labeling in support of immunotherapy manufacturing.* Provides for batch record review and disposition of immunotherapy products.* Performs lot packet review and disposition of raw materials.* Ensures initiation, investigation, and closure of lot related deviations, non-conformances, and CAPAs.* Provides support for the recall of non-conforming materials, investigations associated with product complaints, and biological product deviation reports.Job Requirements:* Bachelor's degree in a scientific discipline or equivalent.* Typically 7 years related experience in cGMP/FDA regulated industry.* Typically 3 years leadership experience.* Knowledge of cGMP/QSR and FDA device/drug/biologics regulations is required.* Proficient in MS Office applications.* Experience with ERP and/or MRP systems preferred.Working Conditions and Physical Requirements:* May be required to work alternate shifts.* Ability to gown aseptically for work in Clean Room environments.* Some travel may be required.The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: Director, Quality Assurance - NJ Company: Dendreon Corporation Location: Morris Plains, NJ Description: Dendreon Job Postings Director, Quality Assurance - NJ Job Type: Regular Full-Time Location: Morris Plains, NJ Job Description: Dendreon is seeking a Director of Quality Assurance who will provide leadership and support for the implementation of Quality Assurance policies and procedures in support of commercial manufacturing at our New Jersey facility. The successful candidate will provide direct support to Product Development, Manufacturing, Supply Operations and Quality Control in order to prepare the site for FDA inspection. The ability to function in a fast-paced environment and communicate effectively is essential to success. General Summary: Directs overall operational leadership in planning and management of quality systems and activities, including resource management and vendor management, which includes the following: Validation program GMP material review and disposition Internal and external quality audits Pre- and post-approval compliance audit preparation Corrective and preventive action program GMP training program Quality engineering Change control Document control Implements corporate Quality policies ensuring finished products conform to company standards and satisfy GMP regulations. Oversees project risk analysis and develop solutions to a variety of complex problems. Collaborates with other departments during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones. Participates in steering committees that set general business corporate policy and sponsor corporate programs. Interfaces with external customers and FDA during audits and inspections. Mentors and develops department personnel, including supervisory / management staff. Defines framework for department objectives, operation schedule, processes and budgets. Contributes to Quality department strategic management. Job Requirements: Bachelorâ??s degree in a scientific discipline or equivalent. Typically 10 years related experience in cGMP/FDA regulated industry. Typically 5 years experience managing supervisory personnel and contributing toward the development of department strategy. Knowledge of cGMP/QSR and FDA device/drug/biologics regulations. Experience in developing and making formal presentations to executive management. Experience with department budget planning, management and reconciliation. Experience with ERP systems preferred. Working Conditions and Physical Requirements: Ability to gown aseptically for work in Clean Room environments. Some travel may be required. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time. http://www2.recruitingcenter.net/clients/dendreon/publicjobs/controller.cfm?jbaction=JobProfile&Job_Id=10528 http://wrapguy.careercast.com/textjobs/jobs/dendreon_nw/6e5d99bb208fb3516a41d97ff3fe0e7a.html

Job Title: QA Manager for Medical Distributor Company: KSR Location: Piscataway, NJ Description: Kelly Scientific Resources seeks to identify a QA Manager for a medical diagnostic supply distributor who would generate, implement and maintain internal quality procedures and systems to comply with applicable regulatory requirements. This is a temp-to-hire opportunity for an individual with expertise in Quality Assurance, capable of responding to FDA complaints and effectively bringing a company up to compliance. Responsibilities will include establishing a company wide training program in keeping with cGMP requirements; ensuring effective document control and change control processes; implementing effective CAPA Programs; and establishing an effective process for the maintenance of customer complaint records and resolutions. Our client is a relatively small, traditional company with global partners. This position is a new role created out of necessity due to the rate at which this company is growing. They are looking to hire immediately! The contract period will be roughly 3-6 months. Pay: $40-45/hr For immediate consideration, press the APPLY NOW or SUBMIT RESUME button below.

Job Title: Director of Quality Assurance - Medical Device Manufacturing Company: MRINetwork Location: Paterson, NJ Description: Director of Quality Assurance Medical Devices  A world leader in the medical device manufacturing industry has an opportunity available for a Director of Quality Assurance. This position carries the responsibility for company-wide quality vision and leadership, develops site objectives, and drives quality processes throughout the corporation.  The company manufactures a full line of disposable, durable, and implantable devices in multiple states domestically and in multiple countries globally. Additionally, there is a full pipeline of exciting new products and technologies that will be receiving FDA approval in the near future. This is one of the top ten medical device companies in the world.  This position is located in the Northeastern US. A complete relocation package is available. Please send a resume if you are interested in discussing this position.  QUALIFICATIONS ·         BS or MS in supporting discipline·         15+ years experience in the medical device industry·         Quality system design and implementation experience·         Experience building robustness into processes and creating systems for quality·         Broad knowledge of medical device manufacturing methods·         A successful history demonstrating vision and leadership Please respond to this advertisement by attaching your resume in MS Word format to an email addressed to Register to View and John Boynton at MRI Atlanta Peachtree North will give you a call if you meet the requirements.  Please send a link if you are interested in joining my network of 8000+ industry executives on LinkedIn.                       Keywords, medical devices, abatement absorbable advanced affairs anal analysis analyst anesthesia anesthetic angioplasty aorta aortic appendage antimicrobial arm arrhythmia 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