When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. Location/Division Specific Information
The Support Operations Supervisor is a member of the GMP Manufacturing department in Alachua, Florida whose mission is to deliver a consistent and reliable supply of quality released viral vector drug substance and/or drug product that meets regulatory and internal Quality and Safety standards. How will you make an impact?Hours: 7:30a - 4:30p, Monday - Friday
The Supervisor will lead operations, on-the-floor to ensure safe right-first-time execution of all assigned work and provide strong technical and organization leadership for the GMP manufacturing organization effectively supporting multiple operations. The individual must supervise support operations including but not limited to planning, GMP preparation, and day-to-day operational decision making. The incumbent will work closely with a cross functional team of Quality Assurance, Supply Chain, Facilities, Engineering, and Project Management to ensure production operations are safe and right-first-time. The Supervisor will adhere to all Safety and Quality standards of the organization and contribute to continuous improvement in the areas of Safety, Quality, Delivery, Cost, and People. What will you do?
How will you get here?Education/Experience
- As part of manufacturing organization, the first shift Support Operations Supervisor is responsible for leading day-to-day activities of facility cleaning, stocking, disinfectant prep, autoclave, buffer prep, decontamination, H2O2 fumigation, waste management, equipment maintenance, materials movement, staging, and other duties as assigned to ensure the cleanroom and manufacturing systems are clean and inspection-ready at-all-times.
- Demonstrate skills of a Supervisor, which includes: mentoring and coaching employees, effective delegation, developing process understanding of primary work (cleaning, steam sterilization, disinfectant prep, stocking, waste management), etc.
- Provide on the floor oversight as needed, leading right-first-time production during shift operations.
- Schedule and coordination of associates to complete daily, weekly, and quarterly tasks.
- Perform onsite spot inspections that ensure safety and cleanliness standards are met, and to ensure the facility is in a constant state of inspection readiness.
- Ensure staff are properly trained in operation procedures to support safe, quality operations at all times.
- Ensure meticulously maintained facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards
- Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards
- Adhere to the production schedule, ensuring on-time delivery and efficient production logistics
- Other duties as assigned
Knowledge, Skills, Abilities
- High School Diploma and 8 years of experience in a GMP manufacturing environment
- Will also consider a Bachelor's degree with 4+ years of experience in a GMP manufacturing environment or a Master's degree with 2+ years of experience in a GMP manufacturing environment
- Bachelor or advanced degree needs to be in biochemical engineering, chemical engineering, biochemistry or a related discipline.
- Prior experience as a team or project lead required; direct report experience preferred
- Cleanroom experience preferred
- Buffer or media preparation experience preferred
- Prior ERP experience required; SAP experience strongly preferred
- Autoclave operation experience preferred
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
- Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.)
- Strong interpersonal and communications skills, written and oral
- Solid understanding of applicable regulatory requirements
- Strong working knowledge of Microsoft Office
- Ability to deliver high quality documentation and paying attention to detail
- The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
Posting ID: 556644581Posted: 2020-05-21