QA Specialist
Hays

New Brunswick, New Jersey

Posted in Recruitment Consultancy


This job has expired.

Job Info


The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a QA Specialist in New Brunswick, NJ.

Role Description

• Provides oversight for CMO Batch Production Records. Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
• Assists with Document Control and other QA functions.
• Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.
• Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings.
• Gives guidance to CMO as needed and ensure CMO is compliant with company Quality standards.
• Ensures that all audit items are resolved. Supports site for Inspection. Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time.
• Escalates critical quality problems to Senior Management in a timely manner.

Skills & Requirements

BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
• Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language.
• Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
• Ability to Coordinate Quality oversight and working with other site groups.
• Ability to review Quality documents and ensuring compliance to GMP. Documents to include batch records, logs, and others.
• Ability to be an effective communicator to Management, and line staff.
• Ability to work with other manufacturing teams to implement business objectives.
• Must be very detail oriented and be able to quickly detect errors within documentation.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1144961


This job has expired.

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