QC Microbiology Analyst

Employer
Experis
Location
Harmans, Maryland, US
Salary
Competitive
Posted
May 09, 2021
Closes
Jun 01, 2021
Ref
2162897807
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Greetings,

Experis, a Manpower Group company has an exciting multiple contract opportunity for a QC Microbiology Analyst role at Harmans, MD. This position is a 6+ month contract for one of our key Pharmaceutical clients that is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products.

Job Details:

Industry: Pharmaceutical

Job Role: QC Microbiology Analyst I/II

Location: Harmans, MD, 21077

Duration: 6+ Months. (Possibility for extension)

Job Description:

Top Skills:
  • Must have B.S. or A.S. in a Life Sciences discipline and 1-4 years of relevant experience working in cGMP cleanrooms
  • Must have Experience working in cGMP Quality Control
  • Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility.

Shift Timing:
  • Monday-Friday 2nd Shift 4pm-Midnight
  • Monday - Friday 3rd shift Midnight TO 8:30AM
  • WEEKEND SHIFT- Friday-Monday 8am to 4pm

Job Description:

This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.
  • Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility.
  • Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam
  • Conducts bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples.
  • Ability to isolate and sub-culture microorganisms for identification.
  • Provides input on SOP revisions and may assist in the creation and editing of protocols
  • Builds credibility within the lab group by performing high quality work
  • Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
  • Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
  • Compilation and trending of Environmental Monitoring data for reporting purposes
  • Report and investigate environmental monitoring excursions.
  • Effectively communicates results of own work through discussions and documentation with some input from supervisor
  • Flexibility in following unique campaign requirements that may include off-hour and weekend work
  • Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision
  • Experience with viable and non-viable Environment Monitoring collection instruments.
  • Concentration of aseptic technique and contamination control
  • Streak plating and microbial identification
  • Document writing, data interpretation, presentation, statistical analysis and trending a plus
  • Minimum supervision required on day-to-day activities and accomplished tasks
  • Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor
  • Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs

EDUCATION & PREVIOUS EXPERIENCE:
  • B.S. or A.S. in a Life Sciences discipline and 1-4 years of relevant experience working in cGMP cleanrooms
  • Experience working in cGMP Quality Control
  • Experience with Microsoft Office
  • Familiarity with Good Manufacturing Practices (cGMP's)
  • Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks


Thank You!

Hershita Singhal

Phone - 414-666-8462 Ext - 7147

LinkedIn: linkedin.com/in/hershita-singhal-10ab876b

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