QA Specialist III

Responsibilities:
- Perform batch record review and product disposition in support of clinical trials, registration, validation, and commercial product distribution
- Evaluate compliance of completed manufacturing records (batch records, COC/COA, packaging, and related data) from CMO to ensure accuracy and completeness
- Collaborate with CMC to conduct compound/product specific risk assessments across the drug development process
- Review development and validation protocols and reports
- Ensure compliance with quality systems and internal SOPs, including deviations, OOS, product complaints, CAPAs, change controls, and regulatory requirements
- Provide QA CMO oversight activities to maintain required quality standards
- Retrieve data to support quarterly reporting of quality metrics for Management reviews and KPIs
- Assist with quality risk management frameworks, including Annual Product Quality Report preparation
- Support cGMP compliance audits of internal and GMP suppliers’ quality systems
- Liaise with Regulatory Affairs on manufacturing process changes impacting regulatory filings
- Perform other related duties as assigned

Qualifications:
- Bachelor’s degree in science or equivalent relevant experience with 5+ years combined GxP experience in process development and commercial biotechnology/pharmaceutical industries
- Experience in relevant CMC area (DS, DP) and ability to introduce phase-appropriate quality best practices into CMC development processes
- Experience in a manufacturing setting as a plant Quality person (QA PIP)
- Working knowledge/understanding of quality risk assessment management principles
- Extensive knowledge of GMP regulations and guidance (e.g., FDA, EU, ICH)
- Experience with Quality Assurance systems and processes
- Excellent investigational and QA problem-solving skills
- Ability to manage frequent changes, delays, or unexpected events
- Strong technical writing skills
- Advanced software skills including SharePoint and Veeva
- Ability to work independently under tight deadlines and pressure
- Effective interpersonal/communication skills and teamwork orientation
- Comfortable communicating with all levels of staff, including executives

Benefits:
- 401(k) plan with employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; equity incentive plans; health plans (medical, prescription drug, dental, vision); life insurance and disability; flexible time off; annual Winter Holiday shut down; at least 11 paid holidays