Production Supervisor (Nights/Weekends)

The Supervisor, Production is responsible for leading daily production personnel activities and completing associated documentation in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Supervisor, Production will rely on experience and judgment to plan and accomplish goals. In addition, Supervisors will drive employee and equipment productivity to achieve optimum results, and coordinate labor needs in support of achieving production schedule attainment. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.

Enforce/Maintain clean room protocols by complying with garbing and behavior requirements that align to established cGMP practices and techniques

Enforce/follow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP)

Oversee the set-up, operations, troubleshooting/resolution of equipment

Ensure line clearance/changeovers are completed accurately and efficiently

Supervise direct reports to accurately and efficiently perform responsibilities associated with aseptic or terminally sterilized product preparation, compounding, filling, palletizing, and/or accurate as well as timely completion of batch records and production paperwork

Oversee routine aseptic interventions and cleaning activities

Conduct employee reviews and provide coaching as appropriate; maintain performance and attendance records

Conduct shift hand-off meetings, to ensure support/continuity of production plan

Ensure self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and company policies

Perform other duties as assigned

Ability to comply with and enforce aseptic practices and cleanroom behavior

Ability to hold employees accountable for accurate, complete and timely task execution

Ability to wear full cleanroom garb for up to 5 hours at a time

Ability to manufacture product in a compliant manner employing accuracy and efficiency

Must display sound judgment, ability to seek guidance, and provide clear directions

Strong analytical, listening, verbal/written communication, achieve accuracy without being rushed, efficient time-management, problem-solving, attention to detail, prioritization, organization, interpersonal, computer and conflict management skills

Basic math skills (addition, subtraction, division)

Must be mechanically inclined and physically able to lift up to 20 pounds continuously

Able to stand for extended periods of time and work in confined spaces

Associates degree (highly preferred) and 3 years of experience in a cGMP manufacturing environment. Equivalent combination of education and experience may be considered in lieu of a formal degree.

1 year or more of experience in a supervisory role in industrial setting preferred.