QA Specialist

New Brunswick, New Jersey

Join our team as QA Specialist

Location: New Brunswick (Hybrid)

Position Overview:

  • We are seeking an experienced and detail-oriented Quality Assurance Specialist to oversee Quality operations at our Contract Manufacturing Organization (CMO). This role demands a proactive individual who thrives in a collaborative environment and has a strong background in pharmaceutical or biotechnology Quality Assurance.

  
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 ensures 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.

 
Required Skills:  

  • 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.

If you are a detail-oriented Quality Assurance professional with a passion for excellence, we want to hear from you. Apply today and take the next step in your career with us!

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 

 

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