Catalent Pharma Solutions Inc

Principal Quality Associate, Supplier Audits

Catalent Pharma Solutions Inc • $95K — $115K *
Greenville, NC 27858In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a technical field with 6 years of experience in the pharmaceutical industry, including 3 years in Quality Auditing.
  • Associate degree in a technical field with 7 years of experience in the pharmaceutical industry, including 4 years in Quality Auditing.
  • At least 8 years of experience in the pharmaceutical industry, including 5 years in Quality Auditing, with formal auditing training considered as substitution.
  • Minimum of 5 years in a direct Quality role required.
  • Knowledge of regulations and guidelines for Good Manufacturing Practices in the pharmaceutical industry.
  • Understanding of manufacturing and/or laboratory processes is required.

Responsibilities

  • Conduct supplier audits including both desktop and internal site audits.
  • Utilize TrackWise for managing audits, quality events, and documentation.
  • Perform supplier risk assessments and manage qualification questionnaires.
  • Review quality documentation for compliance with GMP and customer requirements.
  • Manage audit schedules and coordinate activities with internal teams and suppliers.
  • Ensure confidentiality agreements are established before audits.
  • Collaborate with Subject Matter Experts to prepare for supplier audits.
  • Monitor quality metrics, identify trends, and track audit observations for continuous improvement.

Benefits

  • Positive and fast-paced work environment focused on process improvement and innovation.
  • Competitive Paid Time Off plus 8 paid holidays.
  • Immediate medical, dental, and vision benefits upon employment.
  • Tuition Reimbursement for degree completion or new education pursuits.
  • Engagement activities like Music Bingo and Halloween Costume Contests.
  • Employee Resource Groups dedicated to Diversity and Inclusion initiatives.
  • Participation in community engagement green initiatives like Highway Clean-up.
  • Clear career path and annual performance reviews for potential growth.
  • Wellness program with an onsite fitness center promoting mental and physical health.
  • Exclusive discounts from over 900 merchants through Perkspot.
Full Job Description
Principal Quality Associate, Supplier Audits Role

Position Summary

We have an opportunity for a Principal Quality Associate, Supplier Audits, to join our team. This role involves performing and facilitating system-based audits and risk assessments for Supplier Audits and Internal Quality Systems. You will support both non-commercial and commercial audits as well as the Inspection Readiness Program. The position requires strong organizational skills to manage audit schedules, ensure compliance, and maintain quality standards across the organization.

Shift: Monday- Friday, 8:00am-5:00pm
Location: Grenville, NC
100% Onsite

The Role
  • Conduct supplier audits, including desktop and internal site audits, to ensure compliance with quality and regulatory requirements.
  • Use TrackWise for audit management, quality events, and documentation tracking.
  • Perform supplier risk assessments and manage supplier qualification questionnaires.
  • Review quality documentation to verify compliance with Good Manufacturing Practices and customer requirements.
  • Manage audit schedules and coordinate audit activities with internal teams and suppliers.
  • Ensure confidentiality agreements are in place before audit execution.
  • Collaborate with Site Subject Matter Experts to prepare for and support supplier audits.
  • Manage TrackWise audit records and ensure timely responses to client observations and audit findings.
  • Monitor site quality metrics, identify trends, and track audit observations to support continuous improvement.
  • Support regulatory inspections by preparing documentation and coordinating responses to regulatory agencies.
  • Maintain strong client relationships by managing supplier observations, corrective actions, and ensuring timely communication and resolution of audit findings.
  • Other duties as assigned.


The Candidate

Minimum Requirements
  • Bachelor's degree in a technical field with at least 6 years of professional experience in the pharmaceutical industry, including 3 years in a Quality Auditing function.
  • Associate degree in a technical field with at least 7 years of professional experience in the pharmaceutical industry, including 4 years in a Quality Auditing function.
  • In lieu of a technical degree, at least 8 years of professional experience in the pharmaceutical industry, including 5 years in a Quality Auditing function, and completion of formal auditing training may be substituted.
  • At least 5 years of experience in a direct Quality role required.
  • Demonstrated knowledge of regulations and guidelines associated with current Good Manufacturing Practices for the pharmaceutical industry.
  • Knowledge of manufacturing and/or laboratory processes required.


Preferred Skills & Background
  • ASQ Certified Quality Auditor or equivalent certification preferred.


Why You Should Join Catalent
  • Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
  • Competitive Paid Time Off plus 8 paid holidays.
  • Medical, dental, and vision benefits effective day one of employment.
  • Tuition Reimbursement - support to finish your degree or earn a new one.
  • Site-based Employee Engagement activities such as Music Bingo, Puppy Supply Donation Program, Halloween Costume Contests, and more.
  • Employee Resource Groups focusing on Diversity and Inclusion.
  • Environmentally friendly, community engagement green initiatives including regular participation in Highway Clean-up.
  • Defined career path and annual performance review process with potential for career growth on an expanding team.
  • WellHub program promoting physical and mental wellness, including onsite fitness center.
  • Perkspot offers exclusive discounts from approximately 900+ merchants in various categories.


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
Pharmaceuticals & Biotech
Founded
2007
* Ladders Estimates

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