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PDS Tech Inc Cleaning Associate in Alachua, Florida

PDS Tech is seeking candidates for a Cleaning Associate in Alachua, FL

How will you make an impact?

During 2nd shift, The Incumbent prepares disinfectants, autoclaves cleaning supplies, cleans/mops production rooms and associated support areas/corridors, disposal of biohazard waste, stocking of gowning materials, stocking locker room supplies, and removal of regular trash from the warehouse areas and locker rooms. The incumbent must also maintain equipment logs and document equipment usage, and document all other assigned cleaning activities as required by written procedures.

The Cleaning Associate is expected to keep the GMP cleanroom in a constant state of inspection readiness and perform routine tasks such as cleaning, decontamination, waste management, equipment maintenance, materials movement and other duties as assigned to assure the cleanroom and manufacturing systems are clean and inspection-ready at-all-times. The Cleaning Associate will adhere to all Safety and Quality standards of the organization contribute to continuous improvement in the areas of Safety, Quality, and Delivery.

What will you do?

  • Perform cGMP manufacturing activities according to standard operating procedures (SOPs) in accordance with assigned daily tasks and production schedule

  • Meticulously maintain facility 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

  • Ability to learn biopharmaceutical manufacturing processes including but not limited to: cleaning, stocking, disinfectant prep, decontamination, waste management, equipment maintenance, materials movement, staging, etc.

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

  • Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities

  • Other duties as assigned

  • How will you get here? Required:

  • High School DiplomaPreferred:

  • Associate Degree in Life Sciences, Engineering, or Biotechnology or certificate program and one to three years’ industry related experienceExperience:

  • Manufacturing experience preferred

  • Cleanroom experience preferred Knowledge, Skills, Abilities

  • 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 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 poundsWork Hours: Monday through Friday, 3 pm to 11 PM on a FLEX schedule. Overtime, weekend and holidays required to meet project timelines as necessary.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.