Microbiology Analyst

3 days left

Employer
Experis
Location
Harmans, Maryland, US
Salary
Competitive
Posted
Jun 04, 2021
Closes
Jun 15, 2021
Ref
2162816414
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Experis, a ManpowerGroup company has an exciting contract opportunity for an Microbiology Analyst. This position is for one of our key clients, a global biopharmaceutical company that is engaged in the discovery, development and manufacturer of healthcare products.

Please find below Job Description:

Job Role: Microbiology Analyst

Location: Harmans, MD 21077

Duration: 6+ months (High Possibility of Extension).

Shift: Weekend Shift- Friday-Monday 8am to 4pm

Top Skills: Environmental Monitoring, cGMP cleanrooms

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.

Position workweek is Monday through Friday.
  • 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
  • Other duties as assigned
  • 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
  • Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
  • Dependable and can work with minimal supervision on scheduled tasks
  • 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
  • Exercises good judgment in dealing with operational problems
  • Understanding of theory, rationale behind tasks performed
  • Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs
  • Ability to succeed in a team-oriented environment under very dynamic conditions

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
  • 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


Primary Recruiter: Saira Hasan
Recruiter Phone Number: 414-666-8462 Ext - 7168
Recruiter Email:
Your LinkedIn (Link) linkedin.com/in/saira-mohammad-hasan-28480211a

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