Job Title

Job Type Full-timeDescriptionJob SummaryThe Supervisor, Production is responsible for daily coordination and execution of working schedules of people and equipment in Production line. Responsible for supervising operators that conduct Granulation, Drying, Blending, Compression, Pellet coating, Tablets coating and Encapsulation of drug products, including Granules branded, development & generic as well as contract customer products while meeting department quality, safety, delivery, and productivity objectives. Supervisors are highly knowledgeable in cGMPs and good manufacturing practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.JOB DUTIES & RESPONSIBILITIES Operations Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating proceduresDevelops daily/weekly department work schedules, set priorities, and verifies availability of resourcesResponsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilizationResponsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigationEnsure all equipment is working properlyReviews batch records and supporting records prior to submission to Quality Maintains a safe work environmentCompletes in-process, set up checks and verification in alignment with Standard Operating ProceduresCompliance Understands and adheres to good documentation practices (GDP)Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closureObtains knowledge and executes assignments in QMS areas: deviation management and/or change controlConducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closureInitiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processesInitiates work orders for equipment repairs or modificationsCreates, reviews, and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure complianceFollow and comply with company Safety policies and OSHA RegulationsParticipates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions Supervisory Reports production updates and schedule changes to team and/or at daily meetingsAssures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedbackAssigns manpower; initiates documentation of violations and disciplinary action with operators as requiredRequests equipment and facility repairs, or modificationsUnderstands and complies with Union AgreementKeeps manager informed of operations; elevates as needed Leadership Reviews operational performance; drives improvement opportunitiesCounsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communicationConsistently communicate, follow, and enforce SOP's and company policies and guidelines.Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieveInterfaces with suppliers of equipment or products and area consultants/expertsConducts/supports CMO audits or regulatory agency inspections. OTHER or ADDITIONAL RESPONSIBILITIES Any other assignment allocated by Supervisor / Department Head.RequirementsMinimum Education Required- B.A. /B.S. Degree in Science, Business or related field or significant experienceDesired- B.A. /B.S. Degree in Pharmaceutical Sciences, Business management or related area Minimum Experience 5+ years in a supervisory role within Pharmaceutical Manufacturing, Operations, or Quality Department with increasing levels of responsibility or equivalentMust have expereince in OSD Manufacturing with increasing levels of responsibility Knowledge Knowledge of Quality MS (Management Systems), Document MS, and MS Office SuiteSolid understanding of all current state, federal and local standards, and regulations, e.g., cGMP, OSHA, FDA and DEA