Role Description Summary
To perform microbiological testing of pharmaceutical articles following cGMP, GLP and corporate policies and work either independently or as a team to achieve company goals and initiatives.
Description of KEY responsibilities:
Follow established laboratory safety procedures.
Analyze samples using appropriate instrumentation (TOC analyzer, Conductivity & pH Meters, etc.) while following current Methods & Procedures (SOPs).
Perform Microbial Limits Testing and reading/reporting of results.
Perform Suitability Testing /review of results.
Media preparation, qualification and approval for use.
Environmental Monitoring of the facility, reporting of data and interpretation of results.
Water sampling, analysis and reporting of results
Microbial identification/characterization of laboratory isolates (Gram stain, presumptive tests, rapid ID kits, etc.)
Must be able to document all activities in a legible manner following established formats and procedures.
Data trending and assessment of results.
Identify and troubleshoot problems with instrumentation and microbiological/analytical preparations.
Evaluate and review laboratory data generated
Write, revise and review SOPs /Protocols
Train new and current employees.
Skills and specific knowledge required
* Ability to establish priorities and manage multiple projects and activities.
* Excellent written and oral communication skills. Provides clear, concise and effective communications.
* Demonstrated ability in complex problem solving and data analysis
* Computer literacy skills (including MS Word, Excel, PowerPoint).
* Write, revise & review Standard Operating Procedures
* Must work well with all levels of the organization and peers in a dynamic production environment.
* Knowledge in cGMPs as applied to raw materials and finished product testing and purified water systems operation and testing
* Previous QC experience
* Conducting laboratory investigations
* Audits data
* Writes laboratory investigations
Experience and education required
* B.S. in Microbiology or related scientific field with minimum 5-7 years experience in microbiology testing laboratory
* Masters degree
Excellent computer literacy skills (including MS Word, Excel, PowerPoint