Quality Assurance Specialist (cGMP/cGLP) – Direct Hire/Remote Option
Our client, a NC-based biopharmaceutical company with a rich and expanding pipeline, is actively recruiting for a very sharp and self-directed candidate to join its Quality team.
This company is developing several products to treat cancer and other serious diseases. Several products are in Phases II and III of development and it is essential that they have the right people in place to ensure Quality. This QA Specialist will be instrumental in that effort.
Company will offer industry leading wage to attract and retain a star.
Key Things to Note:
- The focus of this role is cGMP/manufacturing compliance. Seek candidates with substantial experience with batch record review/release, deviation investigations, QA audits, etc.
- Role will also involve Analytical work and exposure to analytical test methods, validation, etc. would be a plus.
- The company uses third party vendors for many manufacturing and testing functions. Quality experience in an outsourced environment is preferred.
- The company is based in Research Triangle Park, NC but is open to remote/home-based candidates.
- This is a highly collaborative role involving regular interaction with cross-functional team members and vendor partners. Right candidate will complement strong Quality skills and knowledge with excellent communication and interpersonal skills. We seek a team player.
Responsibilities will include:
- Batch record review/material release
- Identifying/investigating GMP deviations
- Review and disposition of drug product
- Complaint investigations
- Internal and vendor audits
- Initiating and tracking of corrective and preventative actions
- Drafting of QA audit agreements.
- SOP writing
- Review of analytical test methods, test method validations, specifications, etc.
Targeted candidate will offer a BS degree in a scientific discipline and 3+ years of experience in a cGMP Quality role. Prior experience in drug manufacturing processes, batch record review, validation, GMP regulations, internal/external audits and ICH guidelines will all be important.
Other priorities include:
- Experience handling QA tasks in an outsourced setting (CMOs)
- Familiarity with GLP requirements
- Keen attention to detail
- Excellent organizational skills
- Experience in a clinical phase strongly preferred
Finally and critically, we seek a candidate who will work well in a growing company. Flexible, can-do, make-things-happen work style will be important.
Please forward Word resume for prompt consideration. East Coast candidates preferred.