Production Supervisor (Nights/Weekends)
Exela Pharma Sciences
Supervisor, ProductionThe 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.Job Responsibilities:Enforce/Maintain clean room protocols by complying with garbing and behavior requirements that align to established cGMP practices and techniquesEnforce/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 equipmentEnsure line clearance/changeovers are completed accurately and efficientlySupervise 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 paperworkOversee routine aseptic interventions and cleaning activitiesConduct employee reviews and provide coaching as appropriate; maintain performance and attendance recordsConduct shift hand-off meetings, to ensure support/continuity of production planEnsure self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and company policiesPerform other duties as assignedRequired Skills:Ability to comply with and enforce aseptic practices and cleanroom behaviorAbility to hold employees accountable for accurate, complete and timely task executionAbility to wear full cleanroom garb for up to 5 hours at a timeAbility to manufacture product in a compliant manner employing accuracy and efficiencyMust display sound judgment, ability to seek guidance, and provide clear directionsStrong 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 skillsBasic math skills (addition, subtraction, division)Must be mechanically inclined and physically able to lift up to 20 pounds continuouslyAble to stand for extended periods of time and work in confined spacesExperience and Education Requirements: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.
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