Production Associate

Bryllan LLC•Brighton, MI

49d

About The Position

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.

Requirements

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

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.
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.