· Completion of a full suite of Microbial testing across the product portfolio according to written procedures in line with commercial manufacturing schedules.
· Microbiological analysis such as Microlimits and test for specified organisms on API and Excipient samples.
· Performing site environmental monitoring and reading/recording of environmental sample results and the preparation of routine environmental trend reports.
· Interpretation and reporting of isolate speciation results.
· Interpretation and reporting of Endotoxin and sterility testing results.
· Supports review and investigations for out- of trends/out-of specifications.
· Microbial analysis of water (Purified/Potable)
· Growth Promotion of Media.
· Isolate handling and control.
· Bioassay finished product testing.
· Completion of analytical testing in accordance with written procedures as required .
· Review of analytical data to appropriate specifications and protocols
· Support troubleshooting and process optimization as necessary
· Active participation and documentation of Deviation investigations, Corrective actions tasks and Procedural updates
· Completion of associated change control tasks and CAPA's
· Generation of protocols and reports as required supporting product testing etc.
· Support the Lean train testing philosophy
· Coordinates waste management, LEAN/Operational excellence and 5S efforts as required.
· Participate in QC and cross-functional projects as required.
· Assists in the training of QC staff.
· Writes and revises methods, specifications, and SOP's as needed.
· 2+ years of relevant experience and a BS degree in Microbiology or equivalent
· Prior experience in pharmaceutical industry is preferred
· Working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
· Experienced in Aseptic Technique
· Proficient in Microbiological analysis such as Environmental Monitoring, Microlimits testing and media growth promotion.
· Speciation of microbial and fungal isolates using the identification systems such as Malditof, Microseq, Vitek, Biolog, BBL and API kits.
· Proficient in microbiology testing including: Sterility testing, Bioburden testing, endotoxin testing, Growth Promotions etc
· Proficient in the use of laboratory equipment such as, pH & conductivity meters
· Knowledge of Analytical techniques desirable
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists