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System One Senior Environmental Monitoring Associate in King of Prussia, Pennsylvania

TITLE: Senior Environmental Monitoring Associate

LOCATION: King of Prussia, PA

TYPE: Contract to hire

SCHEDULE: Mon-Fri Day Hours

Overview:

Biotech company is looking for an experienced Quality Control- Environmental Monitoring Associate to join their team!

Responsibilities:

  • Conduct environmental monitoring in support of Manufacturing and Quality Control, in ISO certified cleanrooms

  • Perform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed

  • Perform Growth Promotion testing, air sampling, surface monitoring and water testing

  • Maintain housekeeping in the cleanrooms and laboratories

  • Assist the Quality Control department in daily operations, as needed

  • Author and revise QC SOPs, respond to Out of Specification results

  • Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule

  • Employment of myriad analytical equipment in support of product quality

  • Training of other employees as necessary

  • Completion of thorough Manufacturing Investigation Reports (MIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented

    Requirements:

  • Minimum Bachelor of Science degree in a scientific discipline with 4-7 years of environmental monitoring experience in an aseptic environment

  • Knowledge of Current Good Manufacturing Practice and Industry standards

  • Experience in a similar role in the biologics or pharmaceutical industry

  • Excellent verbal, written and organizational skills

  • Must be open to occasional off shift and weekend work

    Benefits

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

    #M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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