NOTE: This is a 2nd Shift Opportunity (Monday-Thursday 1pm-11:30pm)
Overview:
A leading pharmaceutical operation is seeking a Sterile Operations Supervisor to oversee daily coordination of personnel and equipment within Compounding Operations. This hands-on leadership role is responsible for supervising Compounding and Support Technicians involved in batch preparation and drug compounding. The ideal candidate ensures safety, quality, and productivity standards are consistently met in accordance with cGMP guidelines.
Key Responsibilities:
- Lead efforts to maintain a safe, compliant manufacturing environment; conduct safety meetings and investigations.
- Supervise daily operations to meet delivery and production goals.
- Onboard new employees and ensure they understand operational workflows.
- Maintain accuracy of raw materials and finished goods through inventory systems.
- Assist with cycle counts and inventory audits (monthly and annually).
- Conduct monthly audits of Warehouse, Pre-Production, Labeling, and Shipping.
- Supervise pre-production staff to ensure compliance with sanitation and cleanroom protocols.
- Develop and implement time studies to optimize department workflows.
- Ensure adherence to SOPs, validated parameters, cGMP standards, and safety procedures.
- Provide performance feedback, training, and coaching to technicians.
- Adjust staffing and workflow based on production needs and unexpected events.
- Conduct in-process checks and document review in alignment with Good Documentation Practices.
- Lead continuous improvement initiatives and support change control activities.
- Manage CAPA, Deviation, and GMP-related tasks to ensure timely closure.
- Report scheduling changes and request necessary repairs or process improvements.
- Perform gowning and work in cleanroom environments as required.
Qualifications:
- High school diploma or equivalent
- 2-3 years of experience in a cGMP/FDA-regulated pharmaceutical environment
- 1+ year of supervisory or team leadership experience
- Familiarity with 503B pharmaceutical compliance requirements
- Experience training staff on aseptic and gowning techniques
- Legally authorized to work in the U.S.
- Must be able to stand for extended periods
- Ability to lift up to 25 lbs frequently and 50 lbs occasionally
- Willingness to work in compounding, warehouse, and boxing areas
- Ability to wear required PPE including full cleanroom attire ("bunny suit" and goggles)
- Comfortable working around pharmaceutical agents and chemical cleaning supplies