The role involves hands-on production tasks in a GMP-regulated environment, including equipment setup, sanitization, media and buffer preparation, and process monitoring. The ideal candidate has biotech lab experience, particularly in quality control or COVID testing labs, and understands safety protocols, PPE usage, and GMP compliance. Strong communication skills, teamwork, and schedule flexibility are essential.
Responsibilities:
- Perform hands-on operations such as equipment setup, cleaning, and sanitization.
- Prepare buffers and media per manufacturing procedures (MPs) and standard operating procedures (SOPs).
- Execute and monitor critical processes, conduct in-line process testing (e.g., pH, conductivity, LAL).
- Operate lab equipment and perform basic troubleshooting.
- Transfer equipment via push carts or floor dollies into processing suites.
- Follow GMP protocols and execute routine validation protocols.
- Initiate quality reports and contribute to continuous process improvements.
- Draft and revise documentation, including SOPs, MPs, technical reports, and investigations.
- Assist in documentation reviews (e.g., equipment logs, batch records).
- Train staff on hands-on tasks and act as a safety representative when needed.
- Maintain an organized and clean workspace, ensuring PPE compliance (provided by Amgen).
- Perform repetitive tasks while standing for extended periods.
Qualifications:
- High School Diploma/GED with 2+ years of relevant work experience, OR
- Associate’s Degree with 6+ months of work experience, OR
- Bachelor’s Degree
Preferred Qualifications:
- Biotech or lab experience (quality control, COVID testing, Quest Labs, or similar).
- Mechanically inclined with troubleshooting abilities.
- Ability to work rotating shifts, weekends, and holidays.
- Strong attention to detail, teamwork skills, and communication.
- Physically capable of lifting up to 35 lbs, pushing/pulling up to 50 lbs, and standing for long durations.
- Comfortable performing physical tasks like bending, reaching, kneeling, squatting, and using stairs/ladders.
Starting Shift: Wednesday – Saturday, 6:00 AM – 5:00 PM
Other Shifts (Flexibility Required):
- Sunday – Wednesday (6:00 AM – 5:00 PM or 1:00 PM – 12:00 AM)
- Wednesday – Saturday (6:00 AM – 5:00 PM or 1:00 PM – 12:00 AM)
Candidates must be open to transitioning between day and swing shifts as needed.
