Quality Control Micro Analyst

Role Summary

Quality Control Micro Analyst position for a Wednesday to Saturday 1:00pm to 11:30pm shift. Performs microbiological assays related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with SOPs and cGMP/FDA regulation. Responsible for routine environmental monitoring, utilities sampling and testing, gowning and aseptic qualifications, and raw materials, in-process and finished product testing related to drug manufacturing.

Responsibilities

• Environmental monitoring of controlled environments, personnel and clean utilities.
• Microbiological testing and analysis (bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc.) on samples related to environmental monitoring, utility, raw materials, and in-process and final product materials.
• Gowning and aseptic qualifications for personnel.
• Training of employees.
• Peer review of data.
• Technical writing assignments such as SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, change controls, etc.

Qualifications

• Associate QC Analyst: BS/BA in Life Sciences or related field, or equivalent education/experience.
• QC Analyst: BS/BA in Life Sciences or related field, and 12‚Äì18+ months of related experience; or equivalent education/experience.
• Sr. QC Analyst I: BS/BA in Life Sciences or related field, and 4+ years of experience; or equivalent education/experience.
• Sr. QC Analyst II: BS/BA in Life Sciences or related field, and 6+ years of experience; or equivalent education/experience.

Skills

• Working knowledge of Microsoft Office (Word, Excel, PowerPoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.

Education

• As listed in Qualifications (see above).

Additional Requirements

• Prior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing is preferred.