Job Summary
The Quality Assurance Specialist II is a hands-on role responsible for supporting quality systems related to QC and Analytical Development (AD), with a focus on method validation projects and compliance activities. Working under moderate supervision, this role ensures adherence to cGMP standards and regulatory requirements for biologic drug substances and products in clinical development.
Responsibilities
- Perform QA review of AD method validation documentation
- Review and support QC quality system records (deviations, CAPAs, change controls, OOTs)
- Assist with equipment and process validation reviews
- Support inspection readiness and participate in audits
- Author and revise departmental SOPs and forms
- Contribute to continuous improvement of quality systems
- May support quality operations including batch record reviews and product inspections
Qualifications
- BS in biology, chemistry, or related scientific discipline (or equivalent experience)
- Minimum 4 years in QA/QC roles within the pharmaceutical or biotech industry
- Familiarity with cGMP standards for biologics
- Experience with quality systems and documentation practices
- Proficiency with standard office software; experience with Veeva is a plus