Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials

Job Description

Join our team as a Team Leader, Manufacturing Operators at Thermo Fisher Scientific Inc., where you will have the opportunity to contribute to world-class production processes. This role is perfect for an ambitious individual who is passionate about making a difference in the pharmaceutical industry.

Responsibilities

Supervise production activities to ensure processes are performing flawlessly according to SOPs.Complete batch documentation accurately and thoroughly while adhering to quality and safety standards.Assist the Production Manager in daily production activities and approve production cycles.Ensure all operators have completed relevant training before driving any task, closely following protocols.Review, approve, and track personnel-related data and documentation such as absence records and daily attendance.Manage inventory of packaging materials and supplies to prevent shortages.Allocate personnel and equipment optimally and liaise with associated departments for day-to-day issues.Report and assist in investigating quality deviations and troubleshoot related issues.Supervise a team, assign tasks, and provide necessary training.Build and review SOPs/WIs.Ensure adherence to cGMP and GDP.Coordinate preventive and breakdown maintenance, offering operational oversight of CM/PM/Calibration activities.Lead Continuous Improvement activities to improve quality and efficiency.If required, perform formulation, filling, and visual inspection activities as per SOPs and Batch Records.Perform SAP transactions at each manufacturing process step.Follow aseptic techniques and practices strictly in aseptic operations.Carry out cleaning and upkeep of production equipment and areas as needed.Prepare filters for testing and perform FIT (Filter Integrity Testing) as required.Communicate any anomalies observed in a timely manner.Participate in EHS, Business Compliance, cGMP, and other compliance-related matters.Perform tasks according to SOPs and maintain strict GMP compliance at all times.Conduct chemical and mathematical calculations to determine product potency and endotoxin levels as needed.Perform any other duties as assigned by the Manager.

How will you get here?

Education

Minimum NITEC/ITE education/Diploma in a relevant field.

Experience

Minimum 5 years of confirmed experience in the pharmaceutical industry.3 years of team lead experience.

Knowledge, Skills, Abilities

Good understanding of safe working practices and cGMP.Highly motivated to work in the pharmaceutical industry.Able to work as part of a team.Able to work rotating shifts.