What are the responsibilities and job description for the Quality Assurance Specialist position at BioPhase Solutions?
Job Description
Job Description
Quality Assurance Specialist
Location : San Diego, CA (Onsite)
Salary Range : $60 - $65 per hour
Job Summary
BioPhase is seeking a Quality Assurance Specialist to support GMP quality oversight activities for drug substance and drug product manufacturing. This role will be responsible for reviewing batch records, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to maintain quality compliance.
Responsibilities
- Review and approve manufacturing release testing and stability batch records.
- Oversee batch documentation for drug substance (DS) and drug product (DP) at external manufacturing vendors.
- Ensure compliance in supply chain documentation, packaging, and labeling activities.
- Review and approve change controls, deviations, investigations, and OOS / OOT reports.
- Analyze and review analytical chemistry data from external vendors in the US and EU.
- Support QA review of internal and external documents to ensure regulatory compliance.
- Perform QMS data entry for complaints, OOS, and investigations.
- Assist with other QA-related projects and compliance initiatives as needed.
Qualifications
Skills & Abilities
Work Environment & Schedule
Salary : $60 - $65
