Microbiologist

-

`

Job Category

QA - Quality Control

Job Level

Lead

Job Type

Full time

Job Location

US, Santa Rosa, CA

Job Description

This position requires a Bachelor's degree or higher in Microbiology, with minimum of 3-5 years of Pharmaceutical Microbiology testing lab experience with background in test method development and method validation, aseptic processing and sterility assurance. Knowledge of GMP, ISO standards, and regulatory/corporate requirements is an asset.

Direct experience with sterilization validations and testing of medical devices, not limited to aseptic techniques for bio burden and sterility tests, culture maintenance, organism identification and characterization, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls.

 

Key Responsibilities:

  • Receiving and logging samples into the Micro Laboratory
  • Performing Micro analysis of raw material, in-process, finished product, stability samples, water and environmental samples associated with development products according to specifications.
  • Execute and maintain the dose audit and bio burden testing program to support radiation sterilization. Tracking and trending data as well initiating and writing investigations
  • Isolation and identification of organisms grown from test samples, Use standard microbiological techniques to maintain, enumerate, isolate, and/or identify cultures of microorganisms
  • Analyzing validation samples according to validation protocols and investigational samples as directed.
  • Perform Environmental monitoring of the manufacturing and laboratory facilities including cleanroom environments, personnel, water systems, compressed gases, in line with ISO standards.
  • Preparation of reagents, media and solutions for test usage. Includes operation of autoclave for media/equipment preparation and disinfection, Maintaining of media, stock culture and equipment logs
  • Experience in plate counting and sterile techniques
  • Disinfectant qualification, cleaning validation, validation of testing methods for sterility, bacterial endotoxin test, hold time studies related to media, aseptic processing validation, sterilization, manufacturing, facility, utilities, processes, personnel/ environment monitoring and qualification
  • Sterility check incoming media and perform Growth Promotion testing.
  • Co-ordination of samples for bio burden and endotoxin testing.
  • Performs sterilization validations and re-qualifications in line with relevant BS EN ISO standards.
  • Working knowledge of cGMPs as applicable to laboratory environment.
  • Conducting of microbiological tests using various methods such as direct plating, pour plate, membrane filtration and other potential rapid micro methods such as ATP / PCR if needed.
  • Ensure timely release of sterile products from contract sterilizers/ external testing laboratories. Provide input on the resolution of sterility related non-conformances. Ensure records are maintained per company policy, as applicable.
  • Work with contract laboratories to ensure effective communication allowing for testing to be performed accurately as per signed agreements.
  • Provide assistance in training personnel.
  • Extensive experience with identification and out of specification investigations.
  • Qualified candidates must be legally authorized to be employed in the United States. 
  • Assists in non-conformance investigations including deviations, and OOT/OOS related to product results and environmental monitoring results

Skills & Requirements

  • Comprehensive understanding of microbiological test methods and procedures. Includes aseptic technique, room equipment preparation, sanitation and disinfection, use of laminar flow, manifolds, autoclaves, incubators, plate counters etc.
  • Skilled in microbiology techniques, methodology, equipment and supplies.
  • Working knowledge of Microsoft Word, Excel and Power Point.(Is computer literate and competent in the use of Microsoft packages)
  • Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility, Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
  • Working knowledge of cGMPs as applicable to laboratory environment.

 

Knowledge and Education:

  • Degree level qualification in Microbiology.
  • Minimum 3-5 years post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.
  • Familiarity with microbiological aspects of GMP regarding sterile medical devices
  • Comprehensive understanding of microbiological test methods and procedures. Includes aseptic technique, room equipment preparation, sanitation and disinfection, use of laminar flow, manifolds, autoclaves, incubators, plate counters etc.
  • Skilled in microbiology techniques, methodology, equipment and supplies.
  • Working knowledge of Microsoft Word, Excel and Power Point.(Is computer literate and competent in the use of Microsoft packages)
  • Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility, Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
  • Working knowledge of cGMPs as applicable to laboratory environment.

 

Benefits:

NeilMed offers Health, Dental, and Vision Coverage, we also have 401K plans and Life Insurance.  Vacation, Holiday and Sick Leave are all included in the first full year of employment. 


How to Apply

1. Email your resume to jobs@neilmed.com and include the job title in the subject line of the email

2. Any questions or for more information please text or call #707.530.5256



About Company

NeilMed Pharmaceuticals is a leading manufacturer in nasal saline OTC products. We are committed to providing exceptional customer service and satisfaction. We ensure that our products meet the highest level of quality and safety standards. We are always looking for experienced, self motivated, hard working, and dependable individuals to join our rapidly growing company. Qualification requirements will vary depending upon the job you are applying for. We offer competitive salary and benefits.

Company Address