Quality Control Microbiologist I
- Expired: over a month ago. Applications are no longer accepted.
The Microbiologist position is responsible for performing routine and non-routine microbiological testing according to established procedures or approved protocols. Also, provide support to the Quality, Operations, and Manufacturing departments to ensure safe and effective finished product release.
DUTIES AND RESPONSIBILITIES:
- Responsible for performing routine and non-routine microbiological testing according to established procedures or approved protocols.
- Perform microbiological testing on raw materials, finished products, in process samples, and stability samples.
- Experience with common microbiology lab instrumentation is a requirement, especially with but not limited to autoclaves, Incubators, air samplers, light microscope, bio safety cabinet, micro hood, colony counter, etc.
- Working knowledge and practical experience with good manufacturing practices in a microbiology lab environment.
- Perform microbiology testing programs such as Microbial limits testing, Antimicrobial effectiveness testing, Purified water testing, Preservative Effectiveness Testing in compliance with USP, FDA requirements.
- Perform Environmental monitoring of controlled areas, growth promotion on media used in microbiology lab, also perform gram staining.
- Maintain laboratory notebooks/records in compliance with Good Laboratory Practice standards.
- Maintain an adequate inventory of laboratory supplies and manage hazardous waste disposal.
- Preparation of media, reagents and maintenance of microbial cultures used in testing.
- Participate in laboratory investigations, OOS Investigations, technology transfer, validations, and R&D projects.
- Coordination or execution of equipment maintenance & calibration.
· BS in Microbiology, Biology or other related scientific discipline or equivalent experience.
- 2-4 years of relevant Microbiology lab experience in a cGMP regulated environment.
- Understand the fundamentals of gamma sterilization and knowledge of Sterility testing is a plus.
- Familiar with 21 CFR 210/211 & 820.
- Familiar with USP <61> and <62> (TAPC, Y/M and Specified Organism tests) and Antimicrobial effectiveness test. (AET) (USP 51)
- Excellent oral and written communication skills, strong interpersonal skills, and superior organizational abilities.
- Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment.
- Ability to work independently with minimal supervision.
- Must be detail orientated, fast learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
- Strong computer skills utilizing Word, Excel, PowerPoint, Microsoft Office is essential.
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AddressHudson County, NJ
ScienceView all jobs at Manufacturing