Job Details

Title: QC Analyst

Location: Vacaville, CA

Pay rate: $27/hr

Duration: 6+ months contract with extension or full time conversion

With limited supervision, QC Associate I, is responsible for the performance of direct materials testing in accordance with cGMP regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.

Job Responsibilities:

Perform a broad variety of basic and moderately complex tests with documentation according to GMP

Review data and assess against established acceptance criteria

Perform technical review of peer-generated data

Evaluate data to identify trends and/or establish limits

Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed

Identify and troubleshoot technical problems

Identify gaps in systems and procedures

Receive and provide training

Participate in assay transfer and assay validation

Perform equipment qualification / maintenance

Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures

Support the maintenance and compliance of operational areas

Assure and apply GMP throughout operations

Coordinate with customers to support multi-site operational activities

Support internal and external audits and regulatory inspections

Works to meet schedules, timelines, deadlines

Participate in and/or lead group and project teamwork; project and process improvements

Write protocols and reports under limited supervision

Meets scheduled performance of 95% on time

Perform other duties as requested by managers to support Quality activities

Job Requirements:

B.S./B.A. degree and 1-3 years experience or Master's Degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.

Strong verbal and written communication skills, ability to organize and present information both formally and informally.

Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.

Routinely exercises sound judgment, reasoning and problem solving.

Capable of working under limited supervision and determining own short term priorities.