QC Analyst II Job at SGS Consulting, California

QWRCSEhSVnFOMEQ0UzJNRXhBTnVzdWpuOWc9PQ==
  • SGS Consulting
  • California

Job Description

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.

Job Tags

Similar Jobs

J. Gibson Mcilvain

Skilled Cabinet Maker Job at J. Gibson Mcilvain

 ...calculations to ensure alignment of doors, hinges, and side panels, always using blueprints or design plans for reference. Clean and repair all equipment necessary for your work, including handsaws, table saws, skill saws, and a variety of drills and sanding tools Be... 

C-P Systems Corporation

Chemical Engineer Job at C-P Systems Corporation

 ...Location: Cottage Grove, Minnesota / Quapaw, Oklahoma Employment Terms: Permanent, Full Time About the Role The Chemical Engineer will function as an on-site engineer at both Cottage Grove, MN and Quapaw, OK, along with supporting other facilities remotely. Cottage... 

Foxtrot Aviation Services

Aircraft Cleaning Technician - Part Time Job at Foxtrot Aviation Services

 ...join our ever-growing family! Foxtrot provides members of the aviation industry with top-of-the-line aircraft detailing, line service and facility cleaning services. We service a wide variety of aircraft and facilities both large and small! This position is based... 

Jconnect Infotech Inc

Teamcenter Senior Admin Job at Jconnect Infotech Inc

 ...is the requirement with my client. Please let me know if you are available for this role. Title: Teamcenter Senior Admin Location : Remote Duration: Fulltime JOB DESCRIPTION : Must Have Technical/Functional Skills Must have Teamcenter... 

Simple Thread

Senior Visual Designer Job at Simple Thread

Job DescriptionJob DescriptionWe are looking for a thoughtful, detail-oriented designer to be the next member of our growing developer-owned, remote-friendly, people-first, hyphen-loving company.The senior visual designer is responsible for delivering high-impact...