QA Associate II

4 days ago

Mahwah, United States System One Holdings, LLC Full time

Title:Quality Assurance Associate II

Location:Mahwah, NJ area

Schedule:Tues- Saturday 2nd shift 4 PM- 12:30 PM (some flex needed)

Type:Contract to Hire

Responsibilities:

Under direct supervision, the associate supports daily tasks that are essential for maintaining and improving quality systems and adhering to client-specific procedures. Key responsibilities include document management, review of manufacturing batch records, quality control (QC) data, facilitating material releases, overseeing final product releases, and providing essential assistance to the Quality Management as needed.

  • Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
  • Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)
  • Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
  • Release raw material in ERP system as well as on paper.
  • Perform Accessioning of incoming Apheresis.
  • Review Batch record and disposition material of finished product to client.
  • Provides information for Out of Specification and deviations to investigator.
  • Performs line clearance prior to manufacturing operations begins.
  • Supports tech transfer activities.
  • Other duties as assigned.
  • Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
  • Attend all required Quality & Compliance training at the specified interval.
Required:
  • BS or higher education degree in a scientifically related field
  • Experience in a biologics or biotechnology company (1-3 years)
  • Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
  • Working knowledge of GMP and TCTP regulations
  • Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)


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.

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