Microbiology Lab Administrator - Data Review Specialist
Edison-New Brunswick Metro Area, NJ
- Microbiology Lab Administrator (Coordinator/Data Reviewer)
- Bachelor's degree in science-related field (like Microbiology or Molecular Biology) and at least 3 to 5 years of relevant work experience. Master s degree preferred.
Microbiological testing and data review experience.
Strong work experience with CAPAs, deviations and investigations.
Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
Understanding of and ability to apply the regulations associated with 21 CFR 210/211.
HOURS - 10 AM - 630 PM Mon- Fri- Overtime is anticipated
Review microbiological quality control testing data, including sterility, endotoxin, microbial identification, growth promotion, mycoplasma testing and microbiological validation studies.
Review laboratory data for accuracy, clarity, and adherence to GMP, GDP and/or GLP regulations.
Review equipment and test logbooks.
Review third party testing documentation like test results, protocols, report etc.
Perform document maintenance functions like scanning and filing test results.
Support SOP revision and change requests.
Support investigations, deviations and CAPAs.
Support scheduling of lab activities.
Support sample handling related to Microbiology tests.
Support test samples send outs when needed.
Perform activities like lab stocking and expiry date checks for reagents/media.
Ensure periodic maintenance/calibrations are done on all equipments.
Assist with tracking and trending of results, test turnaround metrics etc.
Assist during internal and external audits.
Serve as backup for critical lab tests if needed.
All other duties as assigned by management.
Ability to multi-task, prioritize and meet strict timelines.
Analytical thinking capacity and scientific reasoning capacity.
Ability to complete routine tasks with little or no supervision.
Strong computer, scientific, and organizational skills.
Excellent communication (oral and written) skills.
Ability to keep accurate records, strong attention to details, follow instructions, and comply with company policies.
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Good interpersonal skills are a must.