QC Analyst II

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

Education/Experience:

• 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.
• 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.
• 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.