QC Chemist II/Microbiologist

  • Cork
  • Permanent
  • JO-1907-64630_1562935118

Summary

RESPONSIBILITIES

· 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.

REQUIREMENTS

· 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

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