QC Analyst I

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

Skills:

• Compliance with cGMP regulations
• laboratory testing
• trend analysis
• documentation review

Education/Experience:

• 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.