QC Analyst II

Job Title:     QC Analyst II 

Location:     Vacaville, CA, 95688 

Duration:     6 Months    

Job Type:    Temporary Assignment 

Work Type: Onsite 
 

 
Job Description: 
 

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. 

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 

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.