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Associate, Quality Control
Job Description
Under minimal supervision, this position is responsible for supporting GMP laboratory operations through microbiology and analytical testing, environmental and water monitoring, sample management, and laboratory equipment operation within a fast paced, team oriented QC environment. The role supports manufacturing by ensuring accurate sample collection, testing, documentation, and compliance with all regulatory and site requirements.
Responsibilities:
- Perform environmental monitoring, water sampling, testing, and sample collection and aliquoting from manufacturing facilities
- Support GMP operations through routine microbiology and analytical testing per site methods and SOPs
- Manage samples and associated data, ensuring proper handling, tracking, and documentation
- Complete accurate, timely, and compliant laboratory documentation using electronic systems and lab notebooks
- Operate, maintain, and troubleshoot laboratory equipment and instrumentation as needed
- Participate in laboratory investigations and support audit readiness activities
- Maintain laboratory cleanliness, organization, and general housekeeping standards
- Ensure continuous training compliance and maintain required technical proficiency
- Follow all safety guidelines, cGMPs, CFRs, and applicable regulatory requirements at all times
- Collaborate effectively within a team environment to support site workload needs
- High school diploma/GED+ 2 years work experience OR
- Associates degree and 6 months' work experience OR
- Bachelors degree
Preferred Qualifications:
- Prior laboratory experience in a GMP or regulated environment
- Background in microbiology, biology, chemistry, or related scientific field
- Experience with environmental monitoring or water sampling/testing preferred
- Strong understanding of GMP documentation practices
- Ability to work effectively in a team based, high volume laboratory setting
- Strong attention to detail, reliability, and ability to follow SOPs consistently
- Exposure to laboratory equipment operation and basic maintenance
- Strong communication and organizational skills
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