Microbiology QC Analyst I - Aseptic Testing & GMP

RXinsider LTD.; Columbia (SC); Hybrid; USD 45,000 - 65,000; Full time

Job summary

RXinsider LTD. is seeking a QC Microbiology Analyst I to perform microbiology testing of raw materials, in-process and finished products per USP methods and cGMP guidelines. You will also train staff, review results, and assist investigations to support product release.

The role requires 1+ year of pharma microbiology experience, aseptic technique know-how, and strong documentation skills in a fast-paced laboratory environment.

Qualifications

• Regionally accredited Bachelor's Degree in Biology, Microbiology, or Life Sciences; Master’s preferred.
• At least 1-year experience working directly with Pharmaceutical Microbiology methods.
• 1–2 years of experience in general laboratory skills and aseptic technique.

Responsibilities

• Perform microbiology testing of raw materials, in-process and finished product samples per USP methods and approved procedures.
• Notify Microbiology management of all OOS and OAL results.
• Provide feedback on SOPs, forms, logbooks, etc., to improve procedures.
• Perform routine testing to support release and company needs.
• Train fellow QC lab personnel on QC test methods.
• Interpret test results relative to acceptance of tested lots.
• Generate data for investigations and trend reports; data entry for systems.
• Document and communicate OOS/OOT results and investigations; assist Sample Management with receiving and waste destruction.
• Perform method validation testing when requested.
• Maintain housekeeping and station upkeep in the lab.
• Communicate observations and issues to QC leadership.

Skills

Microsoft Office

cGMP documentation

Interpersonal communication

Multitasking

Problem solving

Regulatory quality systems

Written communication

Willingness to training

Education

Bachelor’s Degree in Biology/Microbiology/Life Sciences

Master’s degree (preferred)

Job description

RXinsider LTD. is seeking a QC Microbiology Analyst I to perform microbiology testing of raw materials, in-process and finished products per USP methods and cGMP guidelines. You will also train staff, review results, and assist investigations to support product release.

The role requires 1+ year of pharma microbiology experience, aseptic technique know-how, and strong documentation skills in a fast-paced laboratory environment.