Performs environmental monitoring of plant utilities and production clean zones using particle counters, contact plates and microbial air samplers.
Performs routine and non-routine microbiological testing such as water bioburden and media growth promotion; Gram staining and microbial identifications.
Performs enumeration and characterization of microorganisms recovered from samples.
Assist with data analysis, troubleshooting and problem solving.
Perform testing according to Standard Operating Procedures (SOPs) and/or GMPs.
Works under direct supervision from management on routine tasks, and with general instructions on new assignments
Works on problems of diverse scope where analysis of data requires a review of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
May support validation activities, troubleshooting and SOP revisions.
Maintains accurate and well-organized laboratory records, notebooks and/or worksheets.
Performs other duties as may be required or necessary.
Follow all hazardous materials and hazardous waste management regulations and guidelines.
Ensure compliance with GMP/HSE regulations, *** policies, procedures and standards as appropriate for the role.
Champion a Quality Culture and ensure a safe working environment.
As appropriate, responsible for implementation of, compliance to, and governance of practices and principles
1 year or more experience in the pharmaceutical industry working in a GMP environment is preferred
· Must have a demonstrated working knowledge of scientific principles.
· Strong oral and written communication skills are required.
Previous hands-on practical laboratory experience is required.
Strong organizational skills are required.
Must have demonstrated problem solving abilities.
Knowledge of FDA regulations and cGMP’s for drugs and device are a plus.
Knowledge of USP and EP tests, such as microbial enumeration tests and bacterial endotoxin test is desirable.
Source: Job Diva – Job Listing