QC Microbiology Analyst

Job Summary

This role will perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations. This will include performing utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases. This role will also perform environmental monitoring of cleanroom suites and laboratory areas as required. This an onsite 3 month contract to start.

location: Pennington, New Jersey

job type: Contract

salary: $58.62 - 68.97 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

Essential Functions of the job:

• Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.
• Perform environmental monitoring of cleanroom suites and laboratory areas as required.
• Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.
  
  

Qualifications

Required:

• Bachelor's Degree or above in Microbiology, Biology or Biotechnology related scientific discipline along with a minimum of 2 years of experience in a QC Microbiology Analyst role or similar position. Will also consider 5 years of experience in a QC Microbiology Analyst role with no higher education. All experience must be from an FDA-regulated biotechnology or pharmaceutical company.
• Experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
  
  

Preferred

• Familiar with USP/EP and cGMP/EU GMP regulations.
• Familiar with instrument and equipment validation.
  
  

skills: PCR, FDA, Microbiology, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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