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Microbiologist

Microbiologist

The Molecular Microbiologist position must understand and follow Quality Manual and Methods relevant to the responsibilities to ensure integrity of test results. Must have the ability to read, understand and apply established protocols and Standard Operating Procedures to perform daily objectives. This position must demonstrate proficiency in aseptic technique, test method validation with a strong background in understanding and utilization of pharmaceutical cGMP as practical laboratory experience and knowledge to microbiological testing. The candidate will have excellent attention to detail, written and effective verbal communication skills with excellent problem-solving and ability to work in a fast-paced environment.

ROLE AND RESPONSIBILITIES

  • 2 years of relevant experience as follow:
  • Perform basic microbiological procedures per USP, FDA/BAM, Modified FDA/BAM, and Standard Methods testing.
  • Duties include but are not limited to:
  • USP <60> Microbiological examination of nonsterile products: Burkholderia cepacia complex (Bcc)
  • USP <61> Microbiological examination of nonsterile products: microbial enumeration tests
  • USP <62> Microbiological examination of nonsterile products: tests for specified microorganisms
  • USP <2021> Microbial enumeration test – nutritional and dietary supplements
  • USP <2022> Microbiological procedures for absence of specified microorganisms-nutritional and dietary supplements
  • USP <51> Antimicrobial Effectiveness Testing
  • USP <55> Biological Indicator Viable Spore Counts
  • USP <1113> Microbial identifications
  • USP <1116> Monthly lab monitoring
  • USP Suitability of Test Methods in the Presence of Product <60>, <61> and <62>
  • USP Preparatory Testing <2021> and <2022>
  • USP <71> Sterility Test
  • USP <85> Bacterial Endotoxins Testing (Gel Clot, Turbidimetric, Chromagenic)
  • USP Growth Promotion Testing
  • Toxicity testing
  • Listeria testing (in-house method)
  • Participate in Validation/Equivalency study of the Soleris NG system (Rapid Micro)

QUALIFICATIONS

  • Bachelor’s in Microbiology or a related scientific field
  • At least 5 to 10 years of experience in a pharmaceutical laboratory.
  • Proficient in aseptic technique.
  • Strong background in pharmaceutical cGMPs.
  • Ability to read, understand and apply established protocols and Standard Operating Procedures to perform daily objectives.
  • Excellent attention to detail.
  • Ability to work on multiple projects and meet timelines.
  • Ability to communicate effectively in both written and verbal formats.
  • Detail oriented with excellent problem-solving skills.
  • Attention to detail and excellent communication skills are also a must!

WORK CONDITIONS AND PHYSICAL REQUIREMENTS

This position must work a minimum of 40 hours a week over a period of 5 days a week and may require additional hours to meet project deadlines. This position does not require traveling.

  • Wear proper protective equipment.
  • Sometimes exposed to loud sounds or distracting noise levels.
  • Are often exposed to contaminants or hazardous conditions while conducting analyses.
  • Work within several feet of others in the laboratory.
  • Sit or stand for an extended period.
  • Be able to lift objects up to 25 pounds.
  • May have to crawl or climb to perform certain tasks like maintenance of an instrument.
  • Repetitive tasks with few breaks.

WE OFFER

  • Generous benefit options
  • Paid training, vacation, and holidays (vacation accrual begins on first day of employment)
  • Career advancement opportunities
  • Education reimbursement
  • 401k program
  • Learning platform
  • And more!

Note: The Company will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. 

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