Quality Associate, Commissioning & Validation
BioSpacea day ago
Highlight
OnsiteFull-timeMid
Summary
Syner-G is seeking a Quality Associate, Commissioning & Validation to join their team in Holly Springs, NC. The role involves supporting the commissioning and validation of a manufacturing facility, ensuring compliance with GMP expectations.
About the Role
As a Quality Associate, you will review, verify, and document that equipment and systems are commissioned, qualified, and validated. You will collaborate with engineering and technical teams to ensure compliance and timely completion of activities. This hands-on role requires attention to detail and the ability to advocate for corrective actions when necessary.
About You
Required:
- Bachelor’s degree in science, engineering, or a related field.
- 2 to 5 years of experience in GMP manufacturing, quality, validation, or commissioning support.
- Working knowledge of equipment qualification and validation lifecycle.
- Familiarity with GMP documentation standards and regulatory expectations.
Preferred:
- Experience supporting facility start-ups, expansions, or tech transfers.
- Exposure to commissioning and qualification of manufacturing equipment or utilities.
- Understanding of FDA, EMA, and ICH GMP expectations.
- Experience working in fast-paced, cross-functional project teams.
Benefits
- Market competitive base salary and annual incentive plan.
- Robust benefit offerings including flexible paid time off and company paid holidays.
- Flexible working hours and remote work options for most positions.
BioSpace
BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.
Holly Springs, NC