Analysis Skills, Assays, Biotech and Pharmaceutical, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Documentation, Equipment Maintenance/Repair, External Audit, GMP (Good Manufacturing Practices), Identify Issues, Internal Audit, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Improvement, Quality Control, Regulations, Reporting Skills, Scientific Principles, Team Lead/Manager, Team Player, Testing, Time Management, Training/Teaching, Trend Analysis, Writing Skills
Position: QC Analyst
Duration: 10+ Months Contract
Location: Vacaville, CA
Job Description:
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.
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Revive Business Solutions