Catalent
pharma and biotech
SeniorSpecialist,ClientQA
“Senior Specialist, Client QA at Catalent. Skills: Client QA, GMP, Quality Assurance, Biologics Manufacturing. Provide QA support for client projects. Provide quality oversight of GMP operations”
What You'll Achieve.
release of manufactured material; delivering high-quality results
Industry & Context.
analytical skills; troubleshooting skills; decision-making skills; resolve complex issues effectively
100% on-site
What They're Looking For.
Must Have
Masters’ degree in a Scientific, Engineering or Biotech field with a minimum of 2 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry, Bachelor’s degree in a Scientific, Engineering or Biotech field with a minimum of 4 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry, Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, EU GMPs, biological manufacturing processes, microbial and cell culture cell banking, fermentation/cell culture, purification, fill/finish, electronic systems, Microsoft products, analytical skills, troubleshooting skills, decision-making skills, work independently, work in cross-functional teams
Nice to Have
LIMS, Master Control, Trackwise
What You'll Do.
Provide QA support for client projects
Provide quality oversight of GMP operations
Support clinical and commercial QA activities
Track and present key quality metrics
Collaborate with clients during manufacturing campaigns
Review and approve master batch records
Support GMP departments in reviewing deviations
Perform risk assessments
Maintain and update systems and databases
Support audits and inspections
How You'll Work.
Team & Collaboration
liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit; Collaborate with clients during initial and subsequent manufacturing campaigns; Proven ability to work in cross-functional teams
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