QA Batch Release Specialist (Raw materials, Intermediates, and Finished Product)

CSL Plasma•Holly Springs, NC

About The Position

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state-of-the-art manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Reporting to the QA Manager, the QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Ability to prioritize record review and usage decisions to support business needs and communicating release needs throughout the organization.

Requirements

University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
Knowledge of current Good Manufacturing Practices (cGMP) principles
Knowledge of FDA and EMA requirements

Responsibilities

Responsible for certification and/or rejection of incoming material, manufactured material, including intermediates, buffers, virus seed, monobulk and drug product in compliance with applicable licenses and legal requirements.
Ensures compliance with regulatory requirements, internal/external guidelines, SOPs, and specifications related to record review and product release.
Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution.
Work closely with key stakeholders concerning batch release requirements.
Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.
Ensure site readiness for regulatory inspections.
Represents batch release area in Health Authority inspections as an SME.
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities.
Authors, reviews, and QA approves Standard Operating Procedures (SOP’s), protocols/reports, work instructions, etc.
Creates and maintains QA SAP Master Data builds in support of batch release.
Data population and approval of Lot Release Protocols.
Supports Lot Release Protocol revisions and GLIMS data builds for LRPs.
Responsible for change control evaluations/actions to assess batch release impact and actions.
Supports batch disposition assessment for deviations as needed.
Gathers, reviews, and verifies data for the Annual Product Reviews.
Ability to answer batch release questions/inquiries, train or coach through progression of experience/knowledge.