Commercial Manufacturing Quality Assurance Specialist
Catalent Pharma Solutions
Summary
We have an opportunity for a Commercial Manufacturing Quality Assurance Specialist to join our team. In this role, you will support quality operations by reviewing batch records, ensuring compliance with FDA guidelines, and maintaining high standards of product quality. You will contribute to continuous improvement initiatives and collaborate with cross-functional teams to uphold regulatory and internal standards.
Job description
Position Summary
We have an opportunity for a Commercial Manufacturing Quality Assurance Specialist to join our team. In this role, you will support quality operations by reviewing batch records, ensuring compliance with FDA guidelines, and maintaining high standards of product quality. You will contribute to continuous improvement initiatives and collaborate with cross-functional teams to uphold regulatory and internal standards.
The Role
- Perform batch record review, product release, and disposition.
- Draft, review, and approve technical documents such as procedures or master batch records.
- Ensure that products are manufactured, tested, and released according to applicable FDA guidelines, regulations, GXPs, and internal standard operating procedures.
- Participate in the development and maintenance of quality assurance programs, procedures, and controls to ensure that products meet established standards and agency guidelines.
- Train, coach, and mentor others on technical, personal development, or business issues.
- Assist in data compilation for annual product review.
- Provide quality assurance advisement for project outcomes and customer interactions.
- Participate in the development and implementation of process-related improvements.
- Assist with manufacturing floor activities, including equipment and room approval and facility compliance.
- Perform other duties as assigned.
The Candidate
Minimum Requirements: Master's degree in a scientific discipline with no experience, or Bachelor's degree in a scientific discipline with 1+ years of experience in Quality Assurance, Quality Control, or Regulatory Compliance in a Good Manufacturing Practice environment, or Associate's degree with 3+ years of experience in an FDA-regulated field and 1+ years in Quality Assurance, Quality Control, or Regulatory Compliance, or high school diploma with 5+ years of experience in an FDA-regulated field and 1+ years in Quality Assurance, Quality Control, or Regulatory Compliance. Six Sigma or American Society for Quality certification preferred.
Requirements
- Master's degree in a scientific discipline with no experience, or Bachelor's degree in a scientific discipline with 1+ years of experience in Quality Assurance, Quality Control, or Regulatory Compliance in a GMP environment, or Associate's degree with 3+ years of experience in an FDA-regulated field and 1+ years in QA/QC/Regulatory Compliance, or high school diploma with 5+ years of experience in an FDA-regulated field and 1+ years in QA/QC/Regulatory Compliance
- Six Sigma or American Society for Quality certification preferred
- Experience in Quality Assurance, Quality Control, or Regulatory Compliance
- Experience in a Good Manufacturing Practice environment
- Experience in an FDA-regulated field
Benefits
- Paid Time Off
- 8 Paid Holidays
- Medical, Dental & Vision
- Tuition Reimbursement
- Career Growth
- Community Engagement
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.