This position is responsible for Quality Assurance Compliance activities supporting deviations, CAPAs, change control, and product releases.
Duties/Responsibilities:
- Support the deviation and CAPA/SCAR Systems by investigating, reviewing, assessing, tracking, follow-up, and completing all quality events.
- Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing all change control documentation.
- Maintain databases and metrics.
- Identify and communicate compliance gaps; propose phase appropriate solutions.
- Track the status of Deviations, CAPAs, and Change Controls.
- Perform internal and/or external audits, as needed.
- Support product releases by reviewing batch records.
- Support risk assessment activities.
- Support audits by regulatory or state agencies and partners.
- Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
- Support other QA department needs as identified by management.
Requirements:
- Bachelor's degree or a combination of relevant education and applicable job experience
- 5+ years' experience in an FDA regulated industry and CGMP regulations.
- Late-phase to commercial phase experience a plus.
- Cell Therapy experience a plus.
In addition to a great culture, we offer:
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
