QC Microbiology Analyst I/II - 2nd Shift

4 days left

Employer
Experis
Location
Severn, Maryland, US
Salary
Competitive
Posted
Jul 09, 2021
Closes
Aug 01, 2021
Ref
2306551130
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
DUTIES & RESPONSIBILITIES:
  • 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


SKILLS & TECHNICAL EXPERTISE:

  • 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
  • Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor


MEASUREMENT OF PERFORMANCE:
  • Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
  • Timeliness and accuracy in completion of projects and documentation (quantity of work)
  • Contributions to projects beyond general responsibilities (quality of work)
  • Identification of problem areas affecting operations (knowledge/problem solving)
  • Offers suggestions for correcting problems and for improving operations
  • Understanding of theory, rationale behind tasks performed
  • Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs


  • 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
  • Strong attention to detail
  • 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

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