Job Description Job Description
Position: QC Analyst II
Location: Vacaville, CA (Onsite)
Pay Rate : $28/hr. on W2
Summary
Under limited supervision, the QC Analyst II is responsible for performing direct materials testing in compliance with cGMP regulations. Key responsibilities include executing laboratory testing, conducting trend analysis, reviewing documentation, supporting investigations (OOS, OOT, OOE), and providing laboratory support. The QC Analyst II collaborates with Quality Control leadership to achieve departmental and organizational goals.
Job Responsibilities
- Perform a variety of basic to moderately complex tests and document results per GMP standards.
- Review data and assess results against established acceptance criteria.
- Conduct technical review of peer-generated data.
- Evaluate data to identify trends and establish limits.
- Identify discrepancies and support the design of quality investigations and CAPA initiatives.
- Troubleshoot technical problems and identify system or procedural gaps.
- Provide and receive training as required.
- Participate in assay transfers and assay validations.
- Perform equipment qualification and maintenance.
- Prepare and maintain standards, controls, stocks, and cultures per procedures.
- Ensure maintenance and compliance of operational areas.
- Apply GMP principles consistently across operations.
- Coordinate with internal customers to support multi-site activities.
- Support internal and external audits and regulatory inspections.
- Meet schedules, timelines, and deadlines; maintain 95% on-time performance.
- Participate in and/or lead group projects and process improvements.
- Write protocols and reports with limited supervision.
- Perform other duties as assigned to support Quality activities.
Job Requirements
- Education & Experience:
- B.S./B.A. degree with 3 years of experience OR
- Master's degree with 1 year of experience OR
- Equivalent combination of education and relevant experience.
- Preferred disciplines: scientific fields within pharmaceutical or biopharmaceutical industry.
- Skills & Competencies:
- Strong verbal and written communication skills.
- Ability to organize and present information effectively.
- Knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
- Strong reasoning, judgment, and problem-solving skills.
- Capable of working independently and setting short-term priorities.
