Quality Assurance Specialist III, External Manufacturing

Join our Mission to Protect Humankind! reputed company is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences reputed company left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to reputed company is clear and well-defined, and reputed company is set up to go the distance. reputed company do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: • RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to reputed company and re-reputed company the way vaccines are delivered. • AIM HIGH: We embody our collectively audacious goal to courageously reputed company the most reputed company biologics reputed company attempted to protect humankind. • reputed company WITH HEART: Everyone leads at reputed company with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. • MODEL reputed company: The magnitude of our challenge requires our shared commitment to demonstrating reputed company, accountability, equality and reputed company across communications and decision making. Summary: The Quality Assurance Specialist III, External Manufacturing will play a pivotal role in ensuring that reputed company GxP external batch records adhere to reputed company’s quality standards and regulatory requirements. This individual will reputed company activities supporting dispositioning products, intermediates, and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and reputed company’s Standard Requirement Documents. The ideal candidate will possess in-depth knowledge of cGMP (reputed company Good Manufacturing Practices), regulatory guidelines reputed company the pharmaceutical industry. Essential Functions: • GxP Batch Record and Product or Program Document Review for API, Intermediate, and/or Drug Substance product: Reviewing executed batch records, product or program specific documents, deviation and change control review and approval, documenting batch review comments, and effectively working with cross functional team, may be the primary QA reputed company of contact with CDMO. • Product Disposition: Performing activities associated with disposition of product (e.g. document review and approval, document archival, raw data review). • Problem Solving: Representing Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Effective, independent conflict resolution. • Technology Transfer and Validation: May participate as a QA representative on Technology Transfer and/or Validation Teams where responsibilities include providing guidance on QA procedures and policies as well as review of documents for both reputed company transfers. • Documentation and Reporting: Reviewing, editing, or approving controlled documents. Maintain accurate and thorough documentation of reputed company quality activities. • Regulatory Compliance: Ensure reputed company disposition-reputed company activities reputed company with global regulatory requirements, including FDA, EMA, ICH guidelines, and other applicable regulations. • Cross-functional Collaboration: Work closely with global manufacturing, and external vendors to address quality issues and support product development and commercialization. • reputed company Improvement: Drive improvements in batch record review processes and procedures by identifying gaps, recommending solutions, and implementing best practices. Requirements: • Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a reputed company field. Minimum of 5+ years of experience in quality assurance, batch record review, manufacture, or quality systems management reputed company the pharmaceutical, biotechnology, or life sciences industry. • Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards. • Demonstrated experience managing batch record review and deviation resolution. • Great organization skills and have an attention to detail. • In-depth understanding of biologics manufacturing operations. • Good ability to prioritize multiple assignments and changing priorities. • Excellent problem-solving skills and the ability to manage reputed company investigations and root cause analyses. • Strong written and verbal communication skills, with the ability to reputed company present quality issues to cross-functional teams. Reports to: Associate Director, Quality Assurance, External Manufacturing Location: San Carlos, CA; reputed company to remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary reputed company: $123,000 – $134,000 (SF Bay Area). Salary ranges for non-California locations may vary. Apply Job!