This position is primarily responsible for managing various Quality Systems and ensuring that the associated documentation, data files, etc. are compiled and maintained according to SOPs and cGMPs. This position will also provide support for the Site Quality Head in the evaluation and monitoring of the Carmel site’s Quality Systems and in the completion of projects as required.
- Responsible for maintaining, evaluating and improving the Carmel site Quality Systems and all associated documentation.
- Responsible for acquiring data from approved Batch Records, for compiling and monitoring metrics / KPIs, and for providing this information and recommendations to the Site Quality Head.
- Manage the Carmel site SOP / controlled documents program, responsible for the document storage area.
- Manage the Carmel site Change Control program, ensure the timely issuance and closure of all Change Controls. Maintain the Change Control database and all completed / archived Change Controls.
- Manage the Annual Product Review program; ensure that APRs are completed in a timely fashion.
- Manage and maintain all employee training records.
- Maintain the Carmel site Equipment list, assign new equipment numbers as required.
- Assist Regulatory Affairs in the gathering of information for Annual Reports.
- Review and approve all incoming receipts of printed materials, provide all approved receipts to the Site Quality Head for SAP system approval.
- Communicate with other departments to provide support and to coordinate activities.
- Assist in the development and presentation of cGMP training to all employees.
- Assist in special projects or other tasks as deemed necessary based on personal qualifications, business needs and QA management’s discretion.
Training or Experience:
- At least 2 years of quality assurance experience in a GMP-regulated pharmaceutical manufacturing site. Prior experience in the identified Quality Systems is preferred.
- Knowledge of GMP, USP/NF, ICH, and FDA guidelines and regulations.
- Excellent oral and written communication skills.
- Expertise in Microsoft Word and Excel, knowledge of SAP preferred.
- Strong troubleshooting, organizational and investigation skills.
- Demonstrated ability to work as part of a cross-functional team.
- A BS Degree is preferred.