Summary:
We are seeking dedicated Manufacturing Associates to join our dynamic team. In this role, you will support development, clinical, and product launch activities within a high-energy production environment. Working under general supervision, you will perform hands-on manufacturing operations and adhere strictly to Good Manufacturing Practices (GMP) to ensure safety, quality, and compliance.
Responsibilities:
- Operate, set up, clean, and sanitize various manufacturing equipment following SOPs and manufacturing procedures (MPs).
- Prepare buffers and media per manufacturing guidelines, ensuring strict adherence to GMP standards.
- Perform and monitor critical production processes, including basic troubleshooting and in-process sampling.
- Operate analytical equipment, collect data, and ensure proper documentation.
- Maintain an organized, clean workspace and uphold a safe, compliant production environment.
- Initiate quality reports and assist in document drafting and revision, including SOPs and MPs.
- Identify, recommend, and implement improvements in manufacturing processes.
- Review production documentation, including equipment logs and batch records.
- Perform physical tasks associated with manufacturing, including lifting up to 35 lbs., pushing/pulling objects requiring up to 50 lbs. of force, and working on your feet for extended periods.
- Work in a clean room environment with protective gear, including steel toe shoes, full gowning, hairnet, and gloves.
- Operate around high-pressure systems and occasionally near heavy equipment.
Skills & Attributes:
- Team-oriented with strong communication and interpersonal skills.
- Strong ethical standards and solid work ethic.
- Problem-solving abilities and initiative.
- Ability to follow directions and policies thoroughly and accurately.
Requirements:
- Education & Experience:
- Bachelor’s degree, OR
- Associate degree with 4 years of relevant experience, OR
- High school diploma/GED with 6 years of relevant experience.
Physical Requirements:
- Ability to lift, push, pull, and move objects up to 50 lbs.
- Perform physical activities such as bending, reaching, climbing, kneeling, squatting, and walking upstairs.
- Standing on portable stairs or ladders up to 6 feet off the ground.
Work Schedule:
- Flexibility is required to work various shifts, including day, swing, graveyard, weekends, and holidays.
- Shifts may vary between 5x8, 4x10, or 3-4x12 hour schedules based on production demands.
