Support Operations Supervisor - GMP - Pharma/Med Device

Support Operations Supervisor - Biotech - Gainesville, FL
Kelly Scientific is seeking an experienced operations supervisor for a biotechnology company in the Gainesville, FL area. 2nd shift. Monday-Friday. This is a direct hire opportunity.
Ideal candidate will have experience in a GMP biotech setting helping to coordinate day to day activities for cleaning, decontamination and material movement.
The Company is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
The 2nd shift Support Operations Supervisor is member of the GMP Manufacturing department 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.
As part of the company's Gene Therapy Site?s manufacturing organization, the second shift Support Operations Supervisor is responsible for leading day-to-day activities of facility cleaning, stocking, disinfectant prep, decontamination, 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.?The incumbent will demonstrate skills of an Supervisor, which Includes: developing process understanding of primary work?(cleaning, steam sterilization, disinfectant prep, stocking, waste management, etc.).
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
Essential Responsibilities:

  • Provide on the floor oversight as needed leading right-first-time production during 2nd shift operations including but not limited to of facility cleaning, stocking, disinfectant prep, decontamination, fumigation, waste management, equipment maintenance, materials movement, staging, etc.

  • Schedule and coordination of cleaning 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.

  • Responsible for ensuring staff are properly trained in operation procedures to support safe, quality operation at all times.

  • Ensure meticulously maintain 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

  • Adheres to the production schedule ensuring on-time delivery and efficient production logistics

  • Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.)

Work Hours: Monday through Friday, 3:00 PM to 11:30 PM on a FLEX schedule. Initial training may be during the standard shift (M-F 6-3) for the first 1-3 Months. Overtime, weekend and holidays required to meet project timelines as necessary.
The Company offers an attractive benefit package to all full time employees which includes; medical, dental, and vision coverage, company paid Disability and Life Insurance benefits, and a 401(k) Plan with a generous company match. All full time employees are also provided with paid time off, paid company holidays, share appreciation rights, and an incentive bonus plan.
Experience and Skills
High School Diploma and 8 years of experience
Bachelor degree with 4+years of experience, Master?s degree with 2+ years of experience
Bachelor or advanced degree in biochemical engineering, chemical engineering, biochemistry or a related discipline.
Strong interpersonal and communications skills; written and oral. Solid understanding of applicable regulatory requirements.

Why Kelly??

With Kelly, you?ll have access to some of the world?s highest-regarded scientific organizations?
providing you with opportunities to work on today?s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you?ll be proud to help
advance. We work with 95 of the Fortune 100? companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career?connect with us today.

Kelly Services?

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


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