QA Operations Specialist I/II
New Hampshire
A leading global life sciences organization located under 50 minutes from downtown Boston, in New Hampshire, is looking to add a QA Operations Specialist to their growing team. This rapidly expanding Biopharmaceutical manufacturing organization just recently received a massive investment to grow their production capabilities, and this position is a direct reflection of that growth.
Responsibilities:
- Work with other departments to ensure the quality of products and compliance to internal procedures and external standards.
- Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
- Provide direction for complex investigations and CAPAs.
- Review and approve CAPAs to prevent recurrence of deviations.
- Ensure site readiness for regulatory inspections
Qualifications:
- Must have experience with RCA, technical writing, risk management, and a history of working with quality related investigations.
- Must have at least 3-4 years of experience in the Pharmaceutical or Biotech industry with a minimum of 2 years supporting late stage clinical and/or commercial production preferred.
- Bachelor's degree in a relevant scientific discipline preferred
This organization is urgently hiring, so make sure you apply NOW before it's too late!