Quality Control Microbiologist in Burlington, MA at AMRI

Date Posted: 5/27/2020

Job Snapshot

Job Description

Description

AMRIprovides global contract research and manufacturing services to thepharmaceutical and biotechnology industries


TheQuality Control Microbiologist is an integral part of the AMRI team and performsquality activities in support of product production and releases. The QCMicrobiologist performs a wide variety of activities to ensure compliance withapplicable regulatory requirements by conducting testing, trending andreporting results.  

Joinour talented workforce, where a commitment to excellence and a customer focusedattitude is everything. We pursue excellence because our work has the power toimprove patients’ lives with the pharmaceuticals we develop and manufacture.

In this position, youwill:

  • 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 laboratoryhousekeeping

Qualifications

      • Bachelor’s Degree in scientific discipline required; microbiology strongly preferred

• 1 years’ industry experience in a GMP,GLP, or pharmaceutical clean roomenvironment

Preferences:

• Knowledgeablein FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus

All interested applicants must apply online. AMRIis an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individualswith disabilities/sexual orientation/gender identity are encouraged to apply.
Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000. Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

Job: Quality
Primary Location: US-MA-Burlington
Other Locations:
Organization: AMRI Burlington
Schedule: Full-time
Job Posting: May 10, 2020, 1:01:20 PM
Shift Type: First Shift

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.