The Production Supervisor role is responsible for safety, quality and performance of the prep, compounding filling area and inspection area. Will be working in an aseptic and non-aseptic area. The role will plan and coordinate all aspects of the production area.
Requirements
- Demonstrated leadership and supervisory skills
- Minimum five (5) years of experience in a regulated industry
- Minimum three (3) years related experience supervision is preferred
- Experience in cGMP manufacturing or clean room production environment is preferred
- Pre-filled syringe experience preferred
- Ability to apply analytical reasoning and root cause analysis to solve problems
- Strong math and calculating skills
- Computer skills
- Ability to read, understand, interpret and implement technical writing and instruction as well as have exceptional ability to solve problems in a fast-paced environment
- Get certified on all the curriculums in the operational area to 1, understand the process and help to improve it. 2. Help to cover breaks, vacancies etc
- Lead cross functional teams to solve urgent production issues, implement improvements
- Work with operational team to improve KPIs or other trends/tasks independently
- Independently investigate pharmaceutical operations and facility nonconformances, identifying any deviations from standards. This includes clearly defining problems, collecting, and organizing existing data, comparing causes to facts, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices
- Review supporting documentation including batch documentation, ancillary documentation, test results / CoAs, product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents
- Assist with deviation/CAPA investigation and understand the process so if needed be able to take over and finalize an investigation/CAPA
- Assist with revision to SOPs pertaining as an SME in the operating area
- Be the SME during internal/external audits, lead presentations and present to the auditing team
- Lead Tier 1 meeting and participate in Tier 2 meeting
- Build a self-sufficient team that can work independently and have very little overview
- Cover for peers and manager if needed
Benefits
- Competitive PTO
- Company closure from December 24th- January 1st
- Bonus program
- Long-Term Incentive Plan
- 401(k) and Profit-Sharing Plan
- Company match
- U.S. Employee Stock Purchase Plan
- 15% Discount
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health, Dependent Care and Limited Purpose Flex Spending and HSA options
- Adoption assistance
- Tuition reimbursement
- Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
- Wellness programs as well as other discounts and perks
