Catalent, Inc

Catalent, Inc

Specialist - Client QA

Harmans, MD

Sponsorship not specified$70k-$90kDetected 7 days ago
Clinical TrialsGMPFDA RegulatoryCell CultureFermentation

About the role

  • This role ensures oversight of GMP manufacturing for cell banks, bulk drug substances, and finished drug products.
  • You will act as the dedicated Client QA Representative, collaborating with clients and internal teams across multiple functions.
  • The position involves reviewing documentation, supporting investigations, and ensuring compliance to enable timely release of materials.

Responsibilities

  • Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
  • We have an opportunity for a Specialist, Client QA to join our team and provide quality assurance support for client projects from start to finish.
  • Address client comments and concerns, attend meetings to provide updates, and manage client interactions as needed.

Requirements

  • Master's degree in a Scientific, Engineering, or Biotech field with 0-2 years of experience in Quality Assurance or Quality Control within biologics, biopharmaceuticals, or a regulated industry, OR
  • Bachelor's degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in Quality Assurance or Quality Control within biologics, biopharmaceuticals, or a regulated industry.
  • Knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210 and 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
  • Ability to quickly learn new and novel manufacturing processes supporting new clients.
  • Knowledge and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
  • Act as the primary contact for client audits, providing back-room support and addressing project-specific questions when required.

Nice to have

  • Preferred Skills & Background
  • Knowledge of LIMS, Master Control, and TrackWise preferred.

Compensation

  • The anticipated salary range for this position in MD is $70,000 - $90,000 Plus Bonus.
  • The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
  • Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
  • Defined career path and annual performance review and feedback process.
  • Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
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