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Production Associate
Production AssociateBiovire • Brighton, MI, USA
Production Associate

Production Associate

Biovire • Brighton, MI, USA
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Biovire is hiring a Production Associate to execute various operations of pharmaceutical manufacturing at the Brighton facility.

The duties of the Production Associate cover several aspects of production, including but not limited to : Dispensing, Inspection, Labeling, Packaging, and Cleaning / Disinfection of the Controlled Production Area. The Production Associate ensures a clean, safe workplace and quality production of drug product adhering to current Good Manufacturing Practices (GMP's).

A Production Associate is a member of the Operations team, responsible for the safe, efficient, and routine manufacturing of drug product.

Essential Duties and Responsibilities :

  • Follow detailed, written instructions (Manufacturing Batch Record, MBR) and procedures (Standard Operating Procedures, SOP's)
  • Accurately complete production documentation in performance of manufacturing operations.
  • Practice and promote safe work habits while performing job functions in compliance with established company and regulatory safety requirements.
  • Ensure quality standards and best practices are followed throughout the manufacturing process.
  • Maintain functional understanding of cGMP's and the impact of deviation from controlled processes and / or procedures.
  • Perform cleaning / disinfection of the Controlled Production Area (CPA) before, during, or after manufacturing processes.
  • Maintain a clean, orderly work environment that remains stocked with materials and supplies.
  • Demonstrate general knowledge and consistent practice of good aseptic technique.
  • Perform other duties as required.

Specific Position Duties and Responsibilities :

  • Verify identity and quantity of components / materials for use in manufacturing.
  • Record GMP data on controlled documentation accurately, precisely, contemporaneously.
  • Transport hazardous and non-hazardous materials into / out of manufacturing area.
  • Wash, sanitize, and utilize material carts / bins / totes.
  • Complete and maintain training records within expected timelines.
  • Identify and help implement process, procedure, safety improvements.
  • Seek value-added tasks during unplanned downtime.
  • Behavioral Expectations :

  • Strong work ethic and ability to accomplish tasks without supervision.
  • Ability to understand abstract concepts, such as sterility, contamination, etc.
  • Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting.
  • Strong mathematical and organizational skills.
  • English communication skills, both written and verbal.
  • Must possess honesty and integrity, commitment to the highest legal and ethical standards
  • Ability to treat every person with courtesy and respect
  • Demonstrate ownership and accountability to production schedule without compromising product quality
  • Desire to work with others and share best practices with colleagues on their shift and on other shifts
  • Knowledge of fundamental cGMP and regulatory principles
  • Physical Requirements :

  • The Production Associate position requires the ability to
  • Routinely lift up to 50 pounds

  • Stand for periods lasting up to 6 hours of an 8-hour shift
  • Properly gown for entry into the controlled manufacturing area
  • Work Experience and Education Requirements :

    An Associate's Degree and / or 2-3 years of equivalent industry experience

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    Production Associate • Brighton, MI, USA

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