Catalent
biologics, biopharmaceuticals, or a regulated industry
LeadQASpecialistClientQA
“Lead QA Specialist - Client QA at Catalent. Skills: Quality Assurance, GMP, Client Projects, Regulatory Compliance. Provide QA support for client projects. Serve as primary QA contact”
What You'll Achieve.
ensuring the quality and compliance of cutting-edge gene therapy products; supporting the release of life-changing therapies; make a direct impact on patient health; delivering high-quality results; meeting client and regulatory requirements
Industry & Context.
analytical skills; troubleshooting skills; decision-making skills; resolve complex issues effectively
100% on-site, Work Schedule: Monday – Friday, 8am – 5pm
What They're Looking For.
Must Have
Masters’ 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, Bachelor’s degree in a Scientific, Engineering or Biotech field with a minimum of 6 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, Ability to quickly learn new and novel manufacturing processes, Proven ability to work independently, Proven ability to work in cross-functional teams, delivering high-quality results, meeting client and regulatory requirements
Nice to Have
LIMS, Master Control, Trackwise
What You'll Do.
Provide QA support for client projects
Serve as primary QA contact
Provide quality oversight of GMP operations
Support clinical and commercial QA activities
Track and present key quality metrics
Collaborate with clients
Review and approve master batch records
Support GMP departments
Review and approve deviations
Perform risk assessments
Maintain and update systems
Support audits and inspections
How You'll Work.
Team & Collaboration
partnering with cross-functional teams; Collaborate with clients; work independently and in cross-functional teams
Communication Scope
client interactions; Track and present key quality metrics; Collaborate with clients
Process & Methodology
project lifecycle, client projects
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