Job: Quality Assurance Specialist (Drug Product/API/Medical Device) – RTP BioPha, Frankel Staffing Partners, RTP, NC
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 API, Drug Product and Drug/Device combo products. Duties will include batch record and supporting document review, 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. Experience assuring Quality over CMO partners will be important.
• This is a QA role in a Manufacturing setting. This role will be a combination of at the desk and “on the floor”.
• This is a highly collaborative role. Seek Quality professional who is a strong communicator and relationship-builder.
• Travel, post-pandemic, is estimated at 10%.
• 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.
• 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
• Support the Product Quality Complaint team as needed, 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.
Targeted candidate will offer a BA/BS degree in a related discipline and 3+ 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, sterile filled finished drug product or medical devices
• Experience handling most tasks described above including batch record review, 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.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.