19 Sep
QA Investigations Lead
New Jersey, Raritan , 08869 Raritan USA

Vacancy expired!

Piper Companies is seeking a QA Investigation Lead in Raritan, NJ to join a Quality Operations team supporting CAR-T manufacturing and overall advancement of the investigational treatment. The QA Investigations Lead will provide quality oversight over production of personalized cell therapy to support clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply. Responsibilities of the QA Investigations Lead include:

  • Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs
  • Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
  • Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
  • Review and approve manufacturing procedures
  • Support regulatory inspections and audits by ensuring inspection readiness within facility
  • Perform internal housekeeping audits
  • Perform analysis on quality indicating data and identifying trends.
  • Provide oversight for trending of quality compliance metrics
Qualificatoins for the QA Investigations Lead include: • B.S. in Science, Engineering or related field • 4+ years' experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices • Must be able to summarize and present results, and experience with team-based collaborations • Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk • Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality • Must be able to discern the criticality of issues and to communicate to management regarding complex issues • Ability to manage conflict and issues that arise with internal or external customers Compensation for the QA Investigations Lead include:
  • $80,000-$100,000 salary, 10% annual bonus, Exempt Employee
  • 10 Paid Holidays plus an additional 3 Floating Holidays
  • 3 weeks' Vacation Days; 5 additional Personal Days; Up to 5 Sick Days

Vacancy expired!

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