Microbiology QC Analyst I: Aseptic Testing & Compliance

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 52,000 - 72,000; Full time

Job summary

RXinsider LTD. in Columbia, SC seeks a QC Microbiology Analyst I to perform microbiology testing on raw materials, in-process, and finished products according to USP methods and cGMP procedures.

The role requires aseptic technique expertise, data interpretation for release decisions, and training of QC staff. 12-hour rotating shifts with documentation and regulatory compliance responsibilities are involved.

Qualifications

• 2–4 years of experience with Microsoft Office programs and learning new systems efficiently.
• Experience with cGMP documentation systems and quality control
• Strong interpersonal, verbal, and written communication skills
• Willingness to receive training in multiple areas
• Knowledge of FDA manufacturing/regulatory quality systems and requirements
• Aseptic technique and regulatory familiarity required
• Ability to manage multiple tasks and meet deadlines

Responsibilities

• Applies microbiological analysis to raw materials, in-process, and finished products (sterility, bioburden, identification, environmental monitoring, growth promotion, media fill).
• Notifies management of all OOS and OAL results.
• Provides feedback on SOPs, forms, and logbooks to improve procedures.
• Performs routine testing to support release and company needs.
• Trains QC lab personnel on test methods.
• Interprets test results for acceptance/rejection of lots.
• Generates data for investigations and enters data into systems; trends reports.
• Reports and initiates documentation of OOS and OOT results.

Skills

MS Office

cgmp knowledge

Documentation skills

Aseptic technique

Regulatory awareness

Education

Bachelor’s degree in Biology/Microbiology/Life Sciences

Master’s degree preferred

Job description

RXinsider LTD. in Columbia, SC seeks a QC Microbiology Analyst I to perform microbiology testing on raw materials, in-process, and finished products according to USP methods and cGMP procedures.

The role requires aseptic technique expertise, data interpretation for release decisions, and training of QC staff. 12-hour rotating shifts with documentation and regulatory compliance responsibilities are involved.