CGMP Compliance Specialist
Perform testing to ensure the microbiological quality of products, manufacturing equipment, process areas, and facility utilities in a manufacturing facility.
This is a shift-based role with extended days (12/7).
Responsibilities:
1. Enter laboratory clean-rooms to collect and log samples for microbial analysis.
2. Conduct bioburden and endotoxin sample analysis according to standard operating procedures.
3. Perform microbial identification through sample analysis.
4. Monitor environmental conditions, including surfaces, settling, and air particulate monitoring in controlled areas.
5. Verify acceptance testing of commercially prepared microbiological culture media.
6. Autoclave microbiological media and laboratory waste as needed.
7. Evaluate all work against regulatory standards, company policies, and SOPs.
8. Complete test records on time and review data from other analysts for accuracy and completeness.
9. Assist in designing and setting up the QC microbiology laboratory and selecting instruments.
10. Participate in validations for drug substances, buffers, and clean utilities qualification programs.
11. Collaborate with manufacturing personnel to identify microbiological root causes and provide technical advice.
12. Transfer methodologies from other test facilities.
13. Maintain laboratory reagents, media, and supplies.
14. Investigate laboratory incidents and generate reports.
15. Implement CAPAs and change controls.
16. Communicate analytical data reports clearly.
Requirements:
* Bachelor's degree in Microbiology or related field.
* 2+ years of validated experience or equivalent combination of education and experience.
* Strong trouble-shooting and problem-solving skills.
* Attention to detail and excellent written and oral communication skills.