Production Associate (Day or Afternoon Shift) 10 percent Shift Premium

GENERAL DESCRIPTION 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 (GMPs).

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

Essential Duties and Responsibilities:

1. Follow detailed written instructions, Manufacturing Batch Record (MBR), and procedures, Standard Operating Procedures (SOPs).
2. Accurately complete production documentation in performance of manufacturing operations.
3. Follow SOPs to complete visual inspection of finished product with the aid of glasses or contact lenses as applicable.
4. Practice and promote safe work habits while performing job functions in compliance with established company and regulatory safety requirements.
5. Ensure quality standards and best practices are followed throughout the manufacturing process.
6. Maintain functional understanding of cGMPs and the impact of deviation from controlled processes and/or procedures.
7. Perform cleaning/disinfection of the Controlled Production Area (CPA) before, during, or after manufacturing processes.
8. Maintain a clean, orderly work environment that remains stocked with materials and supplies.
9. Demonstrate general knowledge and consistent practice of good aseptic technique.
10. Perform other duties as required.

Specific Position Duties and Responsibilities:

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

Behavioral Expectations:

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

Physical Requirements:

28. The Production Associate position requires the ability to: a. Routinely lift up to 50 pounds. b. Stand for periods lasting up to 6 hours of an 8-hour shift. c. Properly gown for entry into the controlled manufacturing area. d. Pass annual vision tests, including color blindness, with or without the aid of glasses and/or contact lenses due to completing routine visual inspection of finished product as an essential job function.

WORK EXPERIENCE AND EDUCATION REQUIREMENTS

• An Associates Degree and/or 2-3 years of equivalent industry experience preferred.
• High School Diploma or GED Required.

Employment at Bryllan Biovire is contingent upon a successful Background check.