Analyst, QC I (Microbiology)
The Quality Control Microbiology, Environmental Monitoring, Analyst I under direct supervision, is responsible for performing microbiological, biochemical, and chemical evaluations of the manufacturing facilities, utilities, and equipment. With experience they would perform as a back-up for QC In-process and QC Microbial ID testing.
Education & Qualifications
- Under direct supervision, the incumbent will be primarily responsible for performing environmental monitoring sampling and testing of the facilities, equipment, and utilities under cGMP guidelines.
- In addition they will be responsible for performing biochemical and microbiological assays of samples under cGMP and GLP guidelines.
- Work assignments will encompass activities from routine to semi-routine in nature with the ability to recognize deviations from accepted limits and practices.
- The incumbent will be responsible for completing assignments in a timely manner, for assisting with troubleshooting, assisting with data trending, and for follow-up on any testing issues or excursions.
- Good record keeping, organizational, written and verbal communication skills are essential.
- Functional activities could include: supporting process validation studies, contributing to investigations, method validations, assay method/procedure development, reagent preparation, in-process microbiological and analytical testing, growth promotion of media, and microbiological identification testing.
- The position requires knowledge of, but is not limited to, aseptic technique, microbial challenge studies, bioburden determination, microbiological method validation, endotoxin, protein, activity, TOC, and other similar analysis methods.
- The incumbent must be willing to work second shift, overtime, weekends, and holidays as required.
- Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience.
- QC cGMP experience beneficial.
- Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.
- Demonstrated working knowledge related to specific functional activities.
- Ability to perform most tasks with supervision.
- Computer literacy is required.
- Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.
- Must have excellent record keeping, written and verbal skills.
- Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays.
- Efficient in scheduling and facilitating the execution of routine and non-routine testing.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance