Sr. QA Specialist

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram. 

JOB SUMMARY:

The Sr. Quality Assurance (QA) Specialist is responsible for ensuring compliance with BioCryst’s Quality Systems in support of small and large molecule drug substance and drug product manufacturing/packaging and testing performed at Contract Manufacturing Organizations (CMOs). The Sr. QA Specialist will be responsible for ensuring compliance with BioCryst SOPs and Policies for all outsourced and internal GMP activities. The Sr. QA Specialist will coordinate and execute the batch review process with internal reviewers to ensure compliance to cGMP. Functions include QA oversight and support for deviations, OOS/OOT investigations, change control, document control, training, validation, internal audits, vendor management, stability program, API receipt and control, cell bank manufacturing, bulk drug substance and drug product manufacturing, packaging and labeling of drug product, and testing of drug substance and drug product for clinical and commercial distribution.  This role has high visibility throughout the organization and therefore requires close coordination across multiple groups with-in BioCryst, e.g., Pharmaceutical Development, QA, QC, Clinical, Regulatory, Safety, Supply Chain and Finance. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Performs all responsibilities in accordance with US and European Drug Substance and Drug Product GMP regulations and associated guidelines, appropriate to the phase of development for both small and large molecule development and commercialization.
• Participates in internal and external project team meetings as the Quality Lead.
• Reviews internal developmental study protocols and reports. Reviews process validation protocols and reports including analytical test results to ensure compliance with approved specifications. Ensures studies, qualifications, and validations are performed per the protocol.
• Reviews cGMP documentation, including, but not limited to analytical/stability data, deviations, OOS investigations, change controls, master batch records and executed records associated with cell banking, drug substance (API), drug product, packaging, and labeling.
• Disposition of master and working cell banks, bulk drug substance, drug product and packaged/labeled product for clinical and commercial distribution. Aseptic knowledge and experience preferred.
• Provides Quality guidance in the resolution of deviations, investigations, and out-of-specification events. Conducts, reviews and/or approves deviations/investigations.
• Participates in qualification of CMOs and monitoring of CMO’s performance. Assists with vendor audits as needed.
• Communicates, written and verbal, with CMOs, service providers, marketing authorization holders, and regulatory authorities.
• Writes and reviews SOPs and Quality Assurance procedures.
• Oversees training activities and prepares training documentation. Presents/participates in GMP/GLP training sessions.
• Assists in hosting audits and regulatory inspections, assists with preparation and performance of internal audits.

 

EXPERIENCE & QUALIFICATIONS:

• Minimum of bachelor’s degree required.
• Minimum of five (5) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required. Knowledge of manufacturing processes is required. Small and large molecule experience preferred.
• Extensive knowledge of US and European Drug Substance and Drug Product GMP req