Experienced Quality Assurance Specialist (Drug Product/Substance) – RTP Pharma/Direct Hire

Our client, a Raleigh area biotech with a growing portfolio of sterile pharmaceutical and combination products, is actively recruiting for a skilled and knowledgeable Quality professional to join its top-notch team.

This is a wide-reaching role supporting the development, implementation, and maintenance of its Quality Assurance systems.  Company will pay excellent wage to attract and retain a star.

Key Things to Note:

• It is a Direct Hire opportunity and an immediate need.
• This QA Specialist will handle Quality functions for both APIs and Drug Products. Duties will include batch record review, complaints, data tracking, supplier deviation investigations, management reporting, etc.  Seek broadly-skilled candidate who enjoys a diverse role.
• The company uses third party vendors for most production and many testing functions.  Quality experience in an outsourced operation will be important.
• This is a QA role in a Manufacturing setting.  Experience working “on the floor” is expected.
• This is a highly collaborative role.  Seek scientist who is a strong communicator and relationship-builder.
• Travel, post-pandemic, is estimated at 25%. 

Selected Responsibilities

• Review finished API and drug product manufacturing and packaging batch records and associated documentation, including Certificates of Analysis (CofA) for cGMP and approved specification compliance.
• Review, investigate and report on Product Quality Complaints, ensuring complaints are recorded, investigated and closed in a timely manner, evaluate complaints for additional reporting obligations (i.e., FAR), prepare trending and reporting periodic reports.
• Support supplier management program including tracking and reporting of supplier communications, change controls, deviations, supplier audits, and investigations related to the production of finished API and drug product
• Provide trending analysis for periodic management review updates on supplier management program.
• Review CMC and other documents in preparation for Regulatory submissions, including IND, NDA, and Annual Reports
• Support the development, implementation and maintenance of the internal Quality Management Systems including, authoring/revising procedures, internal audit, data trending and analysis, APR review, etc.
• Review quality-related documents affecting products including but not limited to: protocols; qualification, validation, and stability reports; test results, including raw data; calibration certificates; temperature charts

Targeted candidate will offer a BA/BS scientific degree and 4+ years performing similar Quality Assurance work in a GMP-regulated manufacturing setting.  Some experience in a sterile setting will be important. 

Other priorities include:

• Understanding of compliance requirements for API manufacturing and sterile filled finished drug product.
• Experience handling most tasks described above including batch record review, product complaints follow-through, vendor deviation investigations, management reporting, etc.
• Ability to read, develop, and understand procedures and other controlled documents.
• Thorough knowledge and understanding of the current Good Manufacturing Practices.  Some experience working “on the floor” is highly preferred.
• Strong written and verbal communication skills including technical writing
• Longevity and growth in previous roles.

Finally, we seek a skilled juggler and problem solver; someone who can switch gears readily, adapt to changing priorities and information, tolerate a dynamic and fast-paced setting, and stay focused on the goal despite disruption or ambiguity.

Please forward Word resume for prompt consideration.  Local candidates only.