Lead Microbiology QC Analyst – Environmental Monitoring

Cellipont; Research Forest (TX); On-site; USD 100,000 - 170,000; Full time

Benefits offered by this job

401K strong employer match

Tuition Reimbursement

Employee Referral Bonuses

Flexible work schedules and PTO

Job summary

Cellipont Bioservices is seeking a QC Lead Analyst, Microbiology to lead environmental monitoring and testing in a fast-paced manufacturing QC environment. The role focuses on evaluating contamination risk, ensuring testing accuracy, and maintaining cGMP compliance for biologic bulk, sterile finished products, and fill/finish processes.

The candidate will own EM qualifications, identify microorganisms, update QC procedures, and collaborate with manufacturing and QA to support client campaigns.

Qualifications

• Bachelor’s degree in biology, microbiology or related field required.
• 4–5 years of relevant industry experience in QC microbiology recommended.
• Strong knowledge of cGMP and regulatory expectations in a QC lab.
• Experience with environmental monitoring, aseptic techniques and microbial testing.
• Excellent data interpretation, reporting and trend analysis skills.

Responsibilities

• Own, execute, and finalize Environmental Monitoring qualifications for cleanrooms.
• Identify objectionable microorganisms and impact to production activities.
• Implement updates to QC procedures and EM programs/policies.
• Cross-train into other QC testing areas as required.
• Compile, trend, and interpret large EM data sets and prepare technical reports.
• Perform routine EM of Grade A-D cleanroom environments and sampling.

Skills

Environmental Monitoring

Aseptic technique

cGMP knowledge

Microbiology testing

Data interpretation

Education

Bachelor's degree in Biology, Microbiology, Biotechnology or related

Tools

Environmental Monitoring instruments

Job description

Cellipont Bioservices is seeking a QC Lead Analyst, Microbiology to lead environmental monitoring and testing in a fast-paced manufacturing QC environment. The role focuses on evaluating contamination risk, ensuring testing accuracy, and maintaining cGMP compliance for biologic bulk, sterile finished products, and fill/finish processes.

The candidate will own EM qualifications, identify microorganisms, update QC procedures, and collaborate with manufacturing and QA to support client campaigns.