Job Title: QC Micro Analyst
Description:
This role involves performing testing to ensure cGMP compliance in the manufacturing facility. The incumbent will be responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
Key Responsibilities:
1. Enter laboratory clean-rooms to collect and log samples for microbial analysis.
2. Perform bioburden and endotoxin sample analysis in line with standard operating procedures (SOPs).
3. Conduct microbial identification analysis.
4. Perform environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
5. Conduct acceptance testing of commercially prepared microbiological culture media.
6. Autoclave microbiological media and laboratory waste as needed.
7. Ensure all work is carried out in compliance with regulatory standards, company policies, and SOPs.
8. Complete test records on time and peer review data from other analysts for accuracy and completeness.
9. Assist in designing and setting up the QC microbiology laboratory and selecting, implementing, and calibrating laboratory instruments.
10. Participate in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs.
11. Provide technical advice to manufacturing personnel in identifying microbiological root causes.
12. Participate in transferring methodologies from other test facilities.
13. Maintain laboratory reagents, media, and supplies.
14. Conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT.
15. Initiate and complete CAPAs and change controls in adherence with site procedures.
16. Communicate analytical data reports clearly and concisely to management.
17. Identify and implement lab process improvements and lean initiatives.
Requirements:
To be considered for this opportunity, you should have a BS/BA or equivalent experience in Microbiology or a related field and 2+ years of validated experience, or an equivalent combination of education and experience.