Quality Assurance Operations Specialist

2 days ago


Durham, North Carolina, United States CARsgen Therapeutics Full time
Job Title: Quality Assurance Operations Specialist

At CARsgen Therapeutics, we are seeking a highly skilled Quality Assurance Operations Specialist to join our team. This role will be responsible for providing day-to-day support of GMP operations at our RTP facility, ensuring the quality and integrity of our clinical and commercial products.

Key Responsibilities:
  • Provide QA oversight of clinical trial drug production, including raw material and product disposition.
  • Support department deliverables/metrics, investigations/deviations, Change Controls, and CAPA's associated with products/process occurring at the site.
  • Interact cross-functionally with Manufacturing, Regulatory, Quality Control, Supply Chain, and Technical Operations teams.
  • Oversee line and production room line clearances, label issuance and reconciliation, and ensure aseptic techniques and good cleaning room behaviors are followed.
  • Support the deviation investigations and ensure on-time closure of the deviations.
  • Provide QA support for QC activities, including the review of QC testing records, SOPs, and reports.
  • Support QA activities for Supply Chain, including the review of incoming materials, SOPs, and reports.
  • Create, revise, and implement quality assurance standard operation procedures and work instructions for the site when necessary.
  • Conduct data analysis to support tracking of Key Quality Performance Indicators and generate quality metrics monthly reports.
  • Support internal and external audits and continuous improvement efforts regarding Operations as it relates to Quality Management processes.
Requirements:
  • 6+ years of experience in the clinical and/or commercial pharmaceutical/biopharmaceutical industry.
  • Good knowledge of biologics cGMP manufacturing, including cell therapy and aseptic processing.
  • Strong interpersonal skills and ability to work collaboratively across functions.
  • Growth-oriented with a continuous improvement mindset and passionate about working in GMP environments.
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.


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