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QC Microbiologist

Employer
PharmaLex
Location
Norwood, Massachusetts, US
Salary
Competitive
Closing date
Nov 29, 2021

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.

General Description:

We are seeking for a Quality Control Microbiologistthat supports microbiological testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at a biopharmaceutical manufacturing facility and affiliated contract organizations. He/she may also support environmental and critical utility monitoring activities. The position will require off-shift hours including nights and weekend. This position asks for availability for all shifts including weekends.

KEY RESPONSIBILITIES AND ACTIVITIES
  • Perform microbiological testing to include but not limited to the following: Culture Purity and Cell Stock Identity, Cell Density Determination, TOC and Conductivity Testing, Endotoxin, Sterility, Bioburden, Biological Indicator Analysis, Growth Promotion Testing, Microbial Identification using Vitek Maldi-TOF.
  • Perform E. coli cell bank testing
  • Perform environmental and critical utility testing.
  • Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies

REQUIRED EDUCATION AND EXPERIENCE
  • BS in a relevant scientific discipline with a minimum of 0-2 years relevant Quality Control experience in a cGMP organization with a focus in Microbiology
  • Familiarity with relevant and current FDA, EU, USP, ICH guidelines and regulations
  • Experience in the execution of kinetic chromogenic endotoxin analysis, Sterility, Bioburden, and Growth Promotion Testing
  • Experience in testing cell lines
  • Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Excellent communication skills (verbal and written)

PharmaLex is an Equal Opportunity Employer.

Job Types: Full-time, Part-time

Salary: $30.00 - $50.00 per hour

Schedule:
  • 8 hour shift
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