Job Title: QC Analyst II
Location: Vacaville, CA, 95688
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite

SUMMARY

• With limited supervision, QC Associate II, 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.

REQUIREMENTS

• B.S. /B.A. degree and three 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.
  Job Type: Contract
  Pay: $24.00 - $26.00 per hour
  Work Location: In perso

• 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