Senior QC Compliance Specialist
Catalent Pharma Solutions
Summary
We have an opportunity for a Senior QC Compliance Specialist to join our team supporting compliance in the Quality Control Analytical Laboratory. This role involves authoring, managing, and tracking investigations, events, deviations, and other quality records. The position also supports compiling, trending, and reporting key quality metrics for management accountability. The successful candidate will help ensure adherence to regulatory standards and continuous improvement of quality systems for GMP manufacturing of biological products.
Job description
Position Summary
We have an opportunity for a Senior QC Compliance Specialist to join our team supporting compliance in the Quality Control Analytical Laboratory. This role involves authoring, managing, and tracking investigations, events, deviations, and other quality records. The position also supports compiling, trending, and reporting key quality metrics for management accountability. The successful candidate will help ensure adherence to regulatory standards and continuous improvement of quality systems for GMP manufacturing of biological products.
The Role
- Support and ensure timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.
- Track and trend aspects of Quality Control Systems and provide management reports identifying risks and trends.
- Collaborate with the Quality Systems group to perform QC CAPA effectiveness evaluations using quantitative and qualitative measures.
- Maintain tracking mechanisms to support QC analytical metrics.
- Monitor and review QC systems and procedures for compliance, quality improvements, and efficiency, providing compliance support to the QC department.
- Participate in QC compliance remediation plans and implementation.
- Assist with the generation and revision of GMP documentation such as standard operating procedures.
- Establish and execute a laboratory audit readiness program to ensure continuous compliance.
- Participate in QC internal audits as applicable.
- Contribute to site quality and process improvement initiatives and represent QC Analytical on project teams.
- Provide protocol generation and execution support for facility and utility qualifications and startups.
- Other duties, as assigned.
The Candidate
- Bachelor's degree in biology or other life sciences discipline with 3–5 years of experience in a quality or compliance function.
- Experience with analytical and/or bioanalytical testing processes.
- Knowledge of scientific and regulatory principles with the ability to enhance quality systems; exposure to Lean Operational Excellence methodologies is highly desirable.
- Experience working in electronic systems such as Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), and Enterprise Resource Planning (ERP) systems is desirable.
- Experience with Good Manufacturing Practices (GMPs).
- Experience with the development, review, and approval of CAPAs, deviations, and investigations within the pharmaceutical or biologics industry, especially in analytical or bioanalytical laboratories.
- Experience with International Council for Harmonisation (ICH) Guidelines, United States Pharmacopeia (USP), and European Union (EU) GMPs.
- Quick to learn and navigate electronic systems, with the ability to work independently or collaboratively in fast-paced environments while applying strong troubleshooting and problem-solving skills.
Preferred Skills & Background
Experience with ddPCR, qPCR, ELISA, pH, osmolality, appearance, CE-SDS, SDS-PAGE, and HPLC.
Requirements
- Bachelor's degree in biology or other life sciences discipline
- 3–5 years of experience in a quality or compliance function
- Experience with analytical and/or bioanalytical testing processes
- Experience with Good Manufacturing Practices (GMPs)
- Experience with development, review, and approval of CAPAs, deviations, and investigations in pharmaceutical or biologics industry
- Experience with ICH Guidelines, USP, and EU GMPs
- Quick to learn and navigate electronic systems
- Ability to work independently or collaboratively in fast-paced environments
- Strong troubleshooting and problem-solving skills
Benefits
- Medical, Dental & Vision
- Paid Time Off
- 8 Paid Holidays
- Tuition Reimbursement
- Performance Bonus
- Career Growth
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.