Experienced QA GMP Associate (Batch Record Review) – NC Pharma – 1 Year Contract – Hybrid

Job Type: 
Life Sciences
Quality Assurance and Quality Control
Other Life Science Positions
Employment Category: 

Our client, a growing Biopharmaceutical company located in the Research Triangle Park has an immediate need for an experienced and detail oriented Quality Assurance Associate to join its QA team.  This role will be focused on batch record review and material disposition of intermediates, drug substance and drug product (manufacturing, packaging and labeling).

This is a Hybrid role, a few days a month in the Durham office will be needed.  This is a contract role expected to last ~ 1 year.  Hourly wage will be generous. 

Specific duties will include:

  • Performing record review necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulations.
  • Conducting reviews of manufacturing processes to ensure compliance.
  • Conducting reviews of testing results in support of release of intermediates, drug product, and packaging.
  • Assisting in deviation/non-conformance identification, review and resolution pertaining to drug manufacturing/packaging.

Targeted candidate will offer a related degree and 5+ years of experience working in Quality in a CGMP Manufacturing Environment. 

Other priorities include:

  • Knowledge of CGMP regulations for US, EU and other markets.
  • Experienced with CGMP documentation review including batch record review, material disposition, and deviations.
  • Industry pharmaceutical experience in both drug substance and drug product.
  • Strong computer, verbal and written communication skills.

Finally we seek a self-starter, a candidate that can take direction and multi-task with ease.  A detail oriented individual who can quickly adjust, shift gears and prioritize is needed here. 

This is an immediate need.  Please forward Word resume for prompt consideration.