Senior Quality Control Microbiologist
2 weeks ago
Atlas Venture is dedicated to transforming the landscape of healthcare through innovative biopharmaceutical solutions. Our commitment is to develop groundbreaking therapies that address unmet medical needs.
Position Summary:We are seeking a highly skilled and experienced Senior Quality Control Microbiologist to join our dynamic team. This role is crucial in establishing and maintaining microbiological quality control programs within our state-of-the-art manufacturing facility.
Key Responsibilities:- Develop and implement comprehensive QC Microbiology systems to meet testing requirements.
- Establish and oversee environmental monitoring programs, including the qualification of cleanroom environments.
- Lead the environmental monitoring initiatives, particularly in aseptic processing areas, and manage any deviations effectively.
- Continuously enhance the environmental monitoring strategy in accordance with regulatory standards and industry best practices.
- Contribute to the development of a robust contamination control strategy.
- Conduct routine QC testing, including bioburden, endotoxin, and microbial identification.
- Manage water sampling and testing protocols to ensure compliance.
- Oversee change control processes and assist in investigations related to QC microbiology.
- Prepare regulatory documentation and support audit processes as necessary.
- Troubleshoot microbiological testing methods and equipment.
- Coordinate microbiology-related studies with external partners and review findings.
The ideal candidate will possess:
- A minimum of 10 years of laboratory experience in a microbiology testing role within a GMP-regulated environment.
- Strong analytical and technical skills, with a preference for those who have experience in laboratory setup and manufacturing support.
- Proficiency in computer applications, including MS Word and Excel.
- Excellent communication and organizational abilities.
- Experience with regulatory audits and inspections is highly desirable.
This position is based in a collaborative and innovative atmosphere, where teamwork and dedication to quality are paramount.
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Senior Quality Control Microbiologist
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2 weeks ago
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