QC Microbiologist Level II in QC Commercial group supporting Microbial and Analytical testing of finished product, API, excipients and packing components.
Duties & 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.
Knowledge, Experience and Skills:
- Technical writing (protocols, reports, procedures)
- The ability to analyse data with a logical approach to problem solving and troubleshooting.
- Excellent spoken and written communication skills.
- Proficient in Microsoft office
- 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
Education & Experience
2+ years of relevant experience and a BS degree in Microbiology or equivalent
Prior experience in pharmaceutical industry is preferred
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.