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Description Position Overview/Summary As a Senior QualityAssurance Engineer (Technical Support) partner with manufacturing and support teams(e.g. MTS, IT/ Lean, ...
Description Description One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with ...
Description Job Description: Quality Engineer, Quality Control Raw Material Operations Genzyme is seeking a Quality Engineer in the Quality Control Raw Material ...
Lab Support has an exciting contract position available for a Quality Assurance Manager with a local, growing company! Responsibilities: Responsible for taking ...
Description One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. ...
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Job Title: Quality Review Consultant Position Description Understanding of the FDA requirements for annual or periodic product quality reviews. Understanding ...
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over ...
Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over ...
For your reference, we have included the original job posting below.
Microbiologist - Quality Control - Req. Code : 941
Job Number:
37406301
Company Name:
AMRI Global
Job Location:
Burlington, MA US
Job Category:
Science & Biotech
Microbiologist - Quality Control - Req. Code : 941
Microbiologist - Quality Control - Req. Code : 941
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Open Date 9/26/2011
Job Title Microbiologist - Quality Control
Education Bachelor's Degree
Location Burlington, MA Burlington, MA 01803, US
Career Level Experienced (Non-Manager)
Category Quality Control
Date Needed By N/A
Job Type Full Time
Travel Required 0
Job Description
Responsible for the environmental monitoring of classified spaces. Perform s, sterility testing, bioburden testing of in-process samples, LAL testing, routine testing of the USP Purified Water systems, WFI, Clean Steam systems and Compressed Gas systems. Supports general QC laboratory functions and assists in the environmental monitoring of aseptic filling operations.
1. Performs sterility and endotoxin testing on finished products. 2. Performs bioburden testing on in-process samples. 3. Performs microbial limit tests on raw materials, in-process samples and finished products. 4. Samples and tests Water for Injection, USP Purified Water systems , Clean Steam systems., and Compressed Gas systems. 5. Performs growth promotion testing on incoming growth media. 6. Performs microbial identifications. 7. Monitors classified clean rooms during manufacturing operations and routine modes for the presence of viable and non-viable particulates. 8. Performs accountability and sterility checks on media fills. 9. Completes and maintains accurate and timely records in accordance with CGMPs. 10. Writes, reviews, and revises SOPs as required. 11. Performs Line Clear/Line Start verifications. 12. Assists in bringing in additional testing capabilities to the microbiology lab as deemed necessary. 13. Other duties as assigned and required.
# of Openings 1
Job Requirements
* Bachelor's degree in the Sciences, preferably Microbiology, and 2-4 years CGMP Experience. * Experience on clean room environment a plus. * Knowledgeable in FDA GMPs (21 CFR, 211), ISO 9001, 13485, and 17025 a plus. * Excellent organizational skills. * Strong oral and written communication skills. * Detail oriented. * Ability to multi-task. * Must be skilled in the use of computers and proficient in word processing, spread sheets, and power point.
