Formulation Supervisor - Third Shift (Lee)

The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel.Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completedResponsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial lossMaintain weekly/daily scheduleUse production schedule and activities, communicate necessary to do tasks to associates and/or leadsCommunicate and maintain the thaw / equilibration schedules for chemicals and/or equipmentMaintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as neededReview Master Production Batch records in timely manner and provides suggestions/corrections to PE memberReview SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframesComplete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for reviewInitiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actionsIdentify safety risks and alerts management to take corrective actionProvide timely communication to management and clients of issues, challenges as well as opportunities for process improvementsOther duties as assignedEnsure all work is conducted following a high standard of GMP compliance and written SOP and batch recordsComply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirementsAssign and direct work, provide direction, resources and resolve problemsParticipate in recruitingProvide feedback on performance to Formulation ManagerTrain team members and ensures proper training is completed prior to assigning tasksFamiliar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech productsExperience:Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of sameLeadership experience as a team lead or supervisor type role preferredBachelor's degree preferredAn equivalent combination of education and experience may be considered