QC Microbiology Analyst I/II

Employer
Experis
Location
Harmans, Maryland, US
Salary
Competitive
Posted
Jun 04, 2021
Closes
Jun 12, 2021
Ref
2162805892
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.
  • Creative individual with outstanding trouble shooting skills
  • 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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