Quality Control Microbiologist in Burlington, MA

Job Snapshot

Job Description

Description

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries The Quality Control Microbiologist is an integral part of the AMRI team and performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. Responsibilities:
• Perform microbiological testing (endotoxin, bioburden) for water
• Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product
• Perform environmental monitoring of the clean rooms (under ISO and EU specifications)
• Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results.
• Perform microbial characterization (gram stain, catalase, oxidase, and couagulase tests)
• Prepare and send out samples for microbiological identification
• Maintain historical files on organisms found in classified areas; microbial identification and trending
• Perform line clear and line start verifications
• Inspection of media fills
• Perform other microbiological assays:
• Sterility ( including Biological Indicator testing)
• Growth promotion testing of all incoming media used in the microbiology
laboratory
• Preservative Effectiveness testing
• Microbial Limits testing
• QC microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure
• Initiate OOS/OT or Environmental Monitoring Excursion Investigations
• Provide Support of general QC Microbiology Laboratory activities
• Chart reading and changing
• Equipment cleaning and maintenance
• Maintaining supplies and inventory
• General laboratory housekeeping

Qualifications

Qualifications
• External
• Bachelor’s Degree in scientific discipline required; microbiology strongly preferred
• Industry experience in a GMP,GLP, or pharmaceutical clean room environment Preferences:
• Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job: Drug Discovery
Primary Location: Burlington, MA
Schedule: Full time
Job Posting: 03/16/2021
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you'd like to view a copy of the company's affirmative action plan or policy statement, please email jobs@amriglobal.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email jobs@amriglobal.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

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