Enable America Jobs

Job Title: QA Specialist

Location: New Brunswick, NJ

Type: Contract

Overview

A Leading pharmaceutical company, with a location in NJ is looking for a QA Specialist to join their team. Candidates with 5+ years of Quality Assurance in a Pharma or Biotech environment experience please apply!

Responsibilities

• 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’s 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.

  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.

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.