Supervisor, Pharmaceutical Coating – 2nd Shift

Key Responsibilities

• Ensure assignments are completed on schedule following established policies and procedures; guide and direct staff to comply with the production schedule.
• Monitor production output and quality versus standards; initiate corrective actions with Production, Quality Assurance, Maintenance, Engineering, etc.
• Ensure proper equipment operation and safety rule compliance; maintain cGMP compliance and cleanliness; prepare/approve rooms and equipment for inspection; perform room releases; keep equipment and room logs current and accurate.
• Coordinate/oversee operators in other areas as needed; act as back-up to other supervisors or the Manager.
• Develop and perform training on production operations, systems, and cGMP compliance as necessary.
• Record/review data on Batch Production Records, in-process sheets, log books, time sheets, deduction cards, and required paperwork; perform controlled substance reconciliations; perform final production review of BPRs prior to Quality approval; obtain corrections and reduce error rates.
• Initiate events/investigations with QA; identify root causes and CAPAs; complete within required time frames.
• Initiate/complete procedural revisions and corresponding training modules across shifts.
• Ensure products are properly labeled and monitor inventories.
• Participate in use of pharmaceutical equipment for process development, scale-up, and validation; coordinate training to transfer new products/processes to commercial operations.
• Provide input for new equipment/upgrades; participate in qualification/requalification.

• Bachelor's degree (or equivalent) and 2-4 years relevant production experience preferred (equivalent education/experience considered).
• Strong communication, time management, organizational, interpersonal, leadership, writing, and basic computer skills (Microsoft Word/Excel, Plateau, Trackwise); knowledge of industry practices/standards.
• Ability to solve routine problems using established policies/procedures.
• Lift up to 50 pounds.
• Ability to stoop, climb ladders/stairs, and stand/sit for extended periods.
• Ability to wear a respirator; hear an alarm; identify small defects; distinguish between colors.

Salary range: $55,000.00-$ USD.

• Competitive salaries and benefits (as stated).