The Microbiologist I is responsible for performing and maintaining the environmental monitoring programs for facilities and water systems. The Microbiologist performs the related functions such as sample collection, operation of test equipment, data analysis, organism identification and trend data entry.
- Perform microbiological testing of raw materials, work -in-process, and finished product for product approval and release.
- Perform and document environmental monitoring of the facilities and water systems in compliance with Standard Operating Procedures.
- Maintain environmental monitoring trend data to drive continuous improvements identify trends and draw conclusions.
- Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions .
- Complete environmental monitoring related investigations and properly document results.
- Perform LAL, water analysis, growth promotion, gram staining, identification of microorganisms and other microbiological testing
- Perform and document environmental monitoring in compliance with Standard Operating Procedures.
- Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
- Maintain laboratory instrumentation required for testing.
- Assist in the review of test data and report any deviations to supervisor.
- Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and object ives.
- Assist management in writing/updating Standard Operating Procedures (SOPs) .
- Participate in projects involving the Quality Control and/or Microbiology departments .
- Train team members in microbiology and chemistry laboratories.
- Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
- Perform other related duties as required
- B.S. in Microbiology or related Science.
- Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods.
- Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system .
- Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods.
- Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)
- Must understand basic lab safety, bio-hazard and chemical waste disposal practices
- Must have a minimum 1 year of practical laboratory experience in a manufacturing environment.
- Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details.
- Knowledgeable of cGMP's and understand the pharmaceutical industry expectations .
- Familiarity with quality systems such as failure investigations, CAPA, calibration, change control, etc.
- 50% Computer/office work.
- 50% in a clean room or laboratory environment.
- Ability to work in an office, laboratory and manufacturing setting.
- Position may require extended hours including evenings and weekends, travel between multiple work sites .
- Must be able to work independently with minimal supervision.
Position may require flexibility in working schedule.
Contact: Phillip Medley, [Click Here to Email Your Resumé] // 513-605-5495
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.