What are the responsibilities and job description for the Senior Operations Manager, Quality Assurance position at Catalent Inc?
Catalent Inc is a global leader in the development and manufacturing of treatments for patients worldwide. The Boston-area facility serves as the company's Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging.
The successful candidate will oversee production activities, ensuring compliance with GMP regulations. This role involves supervising QA Specialists and Senior QA Specialists on the Operations team.
Key responsibilities include:
- Oversight of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies;
- Oversight, review, and approval of Materials Management and Supply Chain activities;
- Oversight of the Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities;
- Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement;
- Initiation, review, approval, and trending of Discrepancies, including Deviations and Investigations;
- Support of implementation of CAPA and review of CAPA effectiveness as determined through Discrepancies. Support review and implementation of Change Controls
- Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods;
- Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials);
- Provide support during compliance inspections conducted by external sources (i.e. health authorities).
Qualifications include a Bachelor's degree in a scientific discipline, preferably in Physical Science or Chemistry, with a minimum of 5 years of Quality Assurance experience in support of GMP production.
The salary for this position is estimated to be around $85,000 per year, based on industry standards and location.
Benefits include a defined career path, diverse culture, positive working environment, potential for career growth, and a comprehensive compensation package.
Salary : $85,000
