Job Description

Job Description

QC Analyst I

Pay Rate: $27.93/hr (W2)

Location: Vacaville, CA

Summary

The QC Associate I performs direct materials testing in accordance with cGMP regulations with limited supervision. Responsibilities include execution of laboratory tests, trend evaluation, documentation review, discrepancy support (OOS, OOT, OOE), and overall laboratory operational support. Partners with Quality Control leadership to meet departmental and organizational goals.

Responsibilities

• Perform a wide range of basic and moderately complex laboratory tests according to GMP.
• Review data and evaluate results based on established acceptance criteria.
• Conduct technical review of peer-generated data.
• Analyze data to identify trends and establish limits.
• Identify discrepancies and support investigation design and CAPA activities.
• Identify and troubleshoot technical issues.
• Recognize gaps in processes, systems, and procedures.
• Provide and receive training as needed.
• Support assay transfers and validation activities.
• Perform equipment qualification and routine maintenance.
• Prepare and maintain standards, stocks, controls, and cultures.
• Ensure compliance and support continuous operational improvements.
• Apply GMP consistently across operations.
• Collaborate with internal teams and external stakeholders for multi-site support.
• Support internal/external audits and regulatory inspections.
• Meet project schedules, timelines, and deliverables.
• Participate in or lead team projects and process improvement initiatives.
• Write protocols and reports with limited supervision.
• Maintain ≥95% on-time performance.
• Perform additional duties assigned by leadership to support Quality initiatives.

Job Requirements

• Education: B.S./B.A. with 1–3 years’ experience or Master’s with 1+ year experience or equivalent. Preferred degrees in scientific fields with relevant experience in pharmaceutical/biopharma.
• Strong verbal & written communication skills; ability to organize and present technical information.
• Demonstrated ability to apply scientific theories and analytical/biological testing techniques.
• Strong judgment, reasoning, and problem-solving skills.
• Ability to work independently and prioritize workload effectively with limited supervision.

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