- Ability to collaborate and communicate effectively with peers and management.
- Bachelor's degree (BA / BS) in Microbiology, Chemistry, Biology, Biochemistry or related field.
- Minimum one (1) year experience working in a microbiological lab, preferably in a regulated GMP industry.
- Proficiency in aseptic technique, serial dilutions, quantitative enumeration of microorganisms, and preparation of test media.
- Experience with microbiological testing such as environmental monitoring
- Good computer skills with knowledge of Microsoft Word, Access and Excel.
- Effective oral and written business communication skills
- Ability to initiate and maintain QC data, documents, reports and corrective action summaries.
- Ability to multi-task, work effectively and complete projects in a fast paced environment.
- Work Environment: Computer workstation and climate-controlled office environment. May occasionally enter production areas where personal protective equipment might be required to prevent or lessens exposure to airborne-borne powdered nutritional supplement substances.
- Experience with Solid dosage products and powders testing
The Microbiologist will perform microbiological testing on raw materials, in-process and finished product as well as environmental samples in a cGMP / GLP laboratory. Reports results in a timely and professional manner to QC Micro Lead / Manager for review. Assists in OOS investigations and excursions reports.
Job Duties and Responsibilities:
Performs routine microbiological testing on raw materials, in-process and finished products using compendial methods such as USP, AOAC, FDA-BAM and in-house validated methods
- Performs retesting of out-of-specification (OOS) results, assists with OOS investigations and OOS reports as directed by micro lead.
- Performs water sampling at various ports
- Performs Environmental Monitoring testing (for air and surface)
- Reviews water and EM test results and assists in investigation of excursions and preparation of relevant reports as directed by micro lead
- Effectively communicates testing progress or project status to Micro Lead.
- Documents and reports results in the appropriate notebooks, logbooks, files and databases.
- Performs formal review of peer notebooks and test results
- Prepares media used for the microbiological analysis of samples.
- Performs timely cleaning and disinfection and handling of biohazard and general wastes.
- Maintains supplies and media inventory for the micro lab in collaboration with peers by creating needed Purchase Requisitions Forms and formally qualifying received media and reagents.
- Operates, maintains and ensures calibration of equipment including thermometers, analytical balances, pipettes and other related equipment used in the micro lab; notifies micro supervisor of potential issues.
- Reviews and revises Standard Operating Procedures (SOP) as directed by Micro Lead
- Assists in implementing cGMP / GLP programs and procedures within the micro laboratory.
- Performs special projects as assigned by QC Manager or Lead
- Complies with cGMP, cGLP, FDA and other applicable industry regulations as well as company policies
Job Family - Quality Control: Conducts a wide range of quality control Microbial tests and analyses on products to uncover defects. Reports to management who make the decision to allow or deny the release. Testing for process monitoring. Testing of Raw Materials and stabilities.
Job Family Group - Quality: Develops and implements programs to establish and maintain quality standards of existing products, and internal systems and processes. Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same.
You may apply for this position online by selecting the Apply now button.
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