Pharma QA Specialist (GCP) - Biologics - North Carolina

4965SMH Pharma QA Specialist (GCP) - Biologics - North Carolina

4965SMH

Pharma QA Specialist (GCP) - Biologics - North Carolina

Location: Durham, NC

Salary Range: $60,000 - $70,000



Come join our growing team and help take this company to the next level! If you're an experienced CLINICAL (GCP) Quality Assurance professional, then read on ...



We're seeking an experienced person to join our team and continue the development of our internal quality systems and procedures. While our requirements (below) for the role are straightforward, your direct QA experience in a GCP setting will take you right to the top of our list for an interview.



Position responsibilities?

· Develop, implement, and maintain internal GCP quality systems and procedures.

· GCP documentation review and approval.

· Internal GCP auditing activities.

· External site audits for compliance with GCP and ICH regulations/guidelines.

· Review data submitted to FDA in support of INDs/BLAs to ensure it is supported by adequate and relevant source documentation.

· May assist in database audits and study report reviews.

· ~25% travel required.



Candidate requirements?

· 5-8 years biopharmaceutical GCP QA experience with a BS degree.

· 2-5 years GCP QA experience with an MS degree.

· Must have experience auditing sites and contractors such as CROs, CMOs, or CSOs for adherence to GCP/ICH standards.

· Must have experience writing and revising controlled GCP documents.

· Must have experience reviewing Protocols, Investigator Brochures, and Informed Consent documents. Experience in reviewing IND/BLA submissions is a plus.

· Ability to analyze data and to assess and resolve complex issues.


In return for your expertise, we can offer you the chance to work with great people in a high energy environment. Moreover, you can work with the best immunotherapy platform there is, enjoying high visibility and a great network! Don't hesitate: send your resume to Scott Hobar for immediate review!



Keywords: QA, Quality Assurance, GCP, clinical, pharma*, clinical trial, biologics, biologic, IND, BLA, FDA, HIV, oncology, immunolog*, infectious disease



Talented employees: those that fit in, add to the culture and exceed expectations are nearly as rare as they are valuable. They have equal parts of drive, personality, boldness and tact. I look to find the right candidate for the right position. If you are an "Impact Player" in the pharmaceutical and biotech industry then we need to talk!

RELOCATION AVAILABLE : YES





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