Supervisor, Pharmaceutical Coating – 5th Shift

Viatris•St. Albans, VT

3d•$30,000 - $49,000

About The Position

The Supervisor, Pharmaceutical Coating guides production staff and ensures assignments are completed on schedule in accordance with established policies and procedures. The role monitors production output, work quality, equipment operation, safety, cleanliness, and cGMP compliance, and coordinates with Production management, Quality Assurance, Maintenance, and Engineering to address issues and take corrective action. The supervisor reviews production documentation, performs required controlled-substance reconciliations, completes final production reviews of Batch Production Records, and helps reduce documentation errors. The role also oversees investigations, procedural revisions, staff training, product labeling and inventory, and the transfer of new products and processes to commercial operations. The supervisor participates in process development, scale-up, process validation, and equipment qualification or requalification.

Requirements

Minimum of a Bachelor of Science degree or equivalent.
2–4 years of relevant experience; a combination of experience and/or education will be considered.

Responsibilities

Ensure assignments are completed on schedule and in accordance with established policies and procedures; guide production staff to meet the production schedule.
Monitor production output and line quality against established standards and initiate corrective actions in collaboration with Production management, Quality Assurance, Maintenance, Engineering, and others.
Monitor equipment operation and compliance with safety rules and guidelines.
Maintain clean, orderly work areas and cGMP compliance; prepare and approve rooms and equipment for inspection, perform room releases as needed, and ensure room and equipment logs are accurate and current.
Coordinate and oversee operators in other areas as needed and provide backup for other supervisors or the Manager.
Develop and deliver training in Production operations, systems, and cGMP compliance.
Record and review Batch Production Records, In-Process Sheets, log books, time sheets, deduction cards, and other required paperwork.
Perform required reconciliations for controlled-substance manufactured lots and complete the final Production review of Batch Production Records before Quality review and approval.
Obtain documentation corrections, monitor error rates, and initiate corrective actions to reduce errors.
Initiate events and investigations in collaboration with QA, identify potential root causes and corrective and preventive actions, assess quality impact, and complete investigations within required timeframes.
Initiate and complete procedural revisions and associated training modules to align practices with procedures and coordinate best practices across shifts.
Ensure products produced or returned to inventory are properly labeled and monitor inventories.
Participate in pharmaceutical equipment use for Process Development, Scale-up, and Process Validation batches, and coordinate training to transfer new products and processes to commercial operations.
Provide input on new equipment and equipment upgrades and participate in equipment qualification and requalification.