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Job Requirements of QC Analyst I:
-
Employment Type:
Full-Time
-
Location:
Vacaville, CA (Onsite)
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QC Analyst I
Tailored Management Services Inc
Vacaville, CA (Onsite)
Full-Time
Job Title: QC Analyst I
Location: 1000 New Horizons Way, Vacaville, CA 95688
Contract Duration: 6+ Months (Potential Extension or FTE Conversion)
Pay Rate: $16.76 – $27.93/hr on W2 + Benefits
Job Summary
Under limited supervision, the QC Analyst I (QC Associate I) is responsible for performing direct materials testing in accordance with cGMP regulations. Responsibilities include execution of laboratory testing, trend analysis, documentation review, and support of discrepancy investigations (OOS, OOT, OOE). The role also supports overall laboratory operations and works closely with Quality Control leadership to meet departmental and organizational goals.
Key Responsibilities
Location: 1000 New Horizons Way, Vacaville, CA 95688
Contract Duration: 6+ Months (Potential Extension or FTE Conversion)
Pay Rate: $16.76 – $27.93/hr on W2 + Benefits
Job Summary
Under limited supervision, the QC Analyst I (QC Associate I) is responsible for performing direct materials testing in accordance with cGMP regulations. Responsibilities include execution of laboratory testing, trend analysis, documentation review, and support of discrepancy investigations (OOS, OOT, OOE). The role also supports overall laboratory operations and works closely with Quality Control leadership to meet departmental and organizational goals.
Key Responsibilities
- Perform a broad variety of basic and moderately complex tests with proper GMP documentation
- 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 quality investigations and CAPA initiatives
- Troubleshoot technical problems and identify system/procedure gaps
- Participate in assay transfer and assay validation activities
- Perform equipment qualification and maintenance
- Prepare and maintain standards, controls, stocks, and cultures per procedures
- Support operational compliance and apply GMP standards throughout processes
- Coordinate with customers to support multi-site operational activities
- Support internal/external audits and regulatory inspections
- Meet schedules, timelines, and performance goals (95% on-time completion)
- Participate in group projects and continuous process improvements
- Write protocols and reports under limited supervision
- Perform additional Quality-related duties as assigned
- B.S./B.A. degree with 1–3 years of experience OR Master's degree with 1 year of experience OR
Equivalent combination of education and experience - Degree in a relevant scientific discipline preferred
- Experience in pharmaceutical or biopharmaceutical industry preferred
- Strong verbal and written communication skills
- Ability to organize and present technical information clearly
- Knowledge of scientific theories and analytical/biological test procedures
- Strong problem-solving, reasoning, and sound judgment skills
- Ability to work independently and prioritize tasks effectively
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