Catalent Pharma Solutions Inc

Manager, Quality Assurance

Catalent Pharma Solutions Inc$90K — $110K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in a scientific discipline.
  • 5+ years of Quality Assurance experience in a GMP environment.
  • Leadership experience at Catalent or relevant external experience.
  • Ability to lift up to 30 pounds.
  • LEAN, Six Sigma, or ASQ certification preferred.

Responsibilities

  • Supervise and guide quality assurance associates in their daily activities.
  • Prepare and deliver performance reviews for team members.
  • Review and release batch documentation for compliance.
  • Approve quality events including deviations and investigations.
  • Review validation documents like Installation and Operational Qualifications.
  • Ensure compliance with quality assurance in construction and facility maintenance activities.
  • Author or revise quality assurance procedures and documentation.

Benefits

  • Defined career path with regular performance reviews.
  • Diverse and inclusive workplace culture.
  • Opportunities for career growth within a growing organization.
  • Competitive paid time off and 8 paid holidays.
  • Community engagement and sustainability initiatives.
  • Comprehensive medical, dental, and vision benefits from the first day.
  • Tuition reimbursement program.
Full Job Description

Manager, Quality Assurance

Position Summary

We have an opportunity for a Manager, Quality Assurance to join our team. In this role, you will lead continuous quality improvement efforts at the site. You will supervise quality assurance associates, ensuring daily activities run smoothly and issues are resolved promptly. This position involves reviewing and approving critical quality documentation and supporting compliance with Good Manufacturing Practices. You will play a key role in maintaining high standards and fostering a culture of quality.

Shift: Monday- Friday, Days
Location: Kansas City, MO
100% Onsite

The Role

  • Supervise quality assurance associates, providing direction for daily activities and resolving issues with internal and external clients.

  • Prepare and deliver performance reviews for assigned associates in both oral and written form.

  • Review and release batch documentation.

  • Review and approve quality events such as deviations, investigations, document control, and change control.

  • Review and approve validation documents, including Installation Qualification, Operational Qualification, and Performance Qualification.

  • Review construction and facilities maintenance activities and plans for quality assurance compliance.

  • Author or revise quality assurance procedures and forms.

  • Identify deviations or investigations during manufacturing or packaging processes and provide direction on appropriate actions.

  • Lead or assist in Good Manufacturing Practice training, including mentoring and developing direct reports.

  • Perform packaging audits.

  • Meet deadlines according to agreed timeframes and communicate adjustments as needed.

  • Other duties as assigned.

The Candidate

Minimum Requirements

  • Bachelor’s degree in a scientific discipline with 5+ years of Quality Assurance experience in a Good Manufacturing Practice environment.

  • Lift up to 30 pounds.

  • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

LEAN, Six Sigma, or American Society for Quality certification preferred.

Why You Should Join Catalent

  • Defined career path with annual performance reviews and feedback process.

  • Diverse and inclusive culture.

  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

  • Competitive paid time off plus 8 paid holidays.

  • Community engagement and green initiatives.

  • Medical, dental, and vision benefits effective day one of employment.

  • Tuition reimbursement.

About Catalent Pharma Solutions Inc

Catalent Pharma Solutions Inc is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. The company operates in four segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. Catalent Pharma Solutions serves customers in various industries, including pharmaceuticals, biotechnology, and consumer health. The company was founded in 2007 and is headquartered in Somerset, New Jersey.
Learn more about Catalent Pharma Solutions Inc
Size
14,000 employees
Industry
Founded
2007

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