QC Analyst II
SGS Consulting
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.
Vacancy posted 3 days ago
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