Sr. QA Specialist

COMPANY:

At Bio Cryst, 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 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  or follow us on Linked In and Instagram.

Sr. Quality Assurance (QA) Specialist is responsible for ensuring compliance with Bio Cryst'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). This position is responsible for ensuring compliance with Bio Cryst SOPs and policies for all outsourced and internal GMP activities. The incumbent 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, cell bank manufacturing, bulk drug substance and drug product manufacturing, packaging and labeling of drug product, and testing of drug substance and product for clinical and commercial distribution. Due to the nature of this role, the ideal candidate must be able to work cross functionally across multiple areas of the organization such Research & Development, Quality Assurance & Control, Clinical Development, Manufacturing Science and Technology (MS&T), Regulatory, Safety, Supply Chain, and Finance.

• 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.
• Acts in the capacity of Quality Lead in internal and external project team meetings.
• 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.
• Acts as Quality SME, reviewer and approver for change controls. Initiates and manages external change controls when necessary, based on vendor notification and Bio Cryst actions required.
• Conducts disposition of master and working cell banks, bulk drug substance, drug product and packaged/labeled product for clinical and commercial distribution. Performs disposition of material received at 3PL warehouse (Starting Materials, Drug Substance, and/or Finished Goods).
• Provides Quality guidance in the resolution of deviations, investigations, and out-of-specification events. Conducts, reviews and/or approves deviations/investigations.
• Works to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and across functional areas assuring the highest levels of quality, compliance, and integrity.
• Collaborates with internal cross-functional teams such as analytical development, technical development, MS&T, Supply Chain, CMC and Regulatory. Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. Escalate issues of critical non-compliance and/or lack of urgency in remediation to Quality management.
• Participates in qualification of Contract Manufacturing Organizations (CMOs) and monitoring their performance. Assists with vendor audits as needed.
• Communicates with CMOs, service providers, marketing authorization holders, and regulatory authorities verbally and in writing on a regular basis.
• Ensures data is recorded in support of department KPIs, GMP quality metrics for Quality Council and Quality Management Review.
• Writes and reviews SOPs and Quality Assurance (QA) procedures.
• Assists and serves as back-up for product quality complaints.
• Oversees training activities and prepares documentation. Presents/participates in GMP training sessions.
• Assists in hosting audits and regulatory inspections, assists with preparation and…