Sterile Drug Microbiology Analyst

STAQ Pharma, Inc.; Columbus (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

STAQ Pharma, Inc. in Columbus, OH is seeking a Laboratory Analyst to perform routine and advanced analytical and microbiological testing to support sterile drug product manufacturing in a 503B outsourcing facility.

You will execute USP methods and ensure all work complies with cGMP and ALCOA+ standards. The ideal candidate has a Bachelor’s degree in a relevant science and 3+ years in a regulated lab, with strong documentation and technical skills.

Qualifications

• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• 3+ years of laboratory experience in a regulated environment (503B, 503A, CGMP, Pharmaceutical QC, GLP, or similar) preferred.
• Working knowledge of USP compendia methods for sterile products.
• Strong understanding of aseptic technique and contamination control.
• Proficiency in Microsoft Office, LIMS/ELN platforms, and data entry.

Responsibilities

• Analytical and Microbiological Testing
• Perform compendia I testing on materials and products including USP <71>, <61>, <791>, <785>, <788>, <790>
• Identify microorganisms using phenotypic platforms (e.g., MALDI-TOF)
• Growth promotion tests, media qualifications, and sterility qualifications
• Method suitability and method verification per SOPs and regulatory guidance
• Support environmental monitoring investigations by analyzing isolates and trends
• Prepare media, reagents, dilutions, and controls for routine testing
• Data Review, Documentation & Compliance
• Record testing activities per ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available)
• Analyze and interpret data to meet specifications and cGMP expectations
• Report atypical, OOS, and OOT results promptly and assist investigations
• Follow SOPs and change control process
• Maintain instrument logs, calibration records, and lab notebooks
• Support quality audits and regulatory inspections
• Equipment Operation & Maintenance
• Operate instruments (OsmoTECH Pro, pH meters, microscopes, particle counters, TOC meters, microbiology ID systems)
• Perform routine instrument calibrations, verifications, and daily checks
• Document equipment usage and maintenance
• Troubleshoot issues and escalate to supervisors/quality/engineering
• Quality, Safety & Continuous Improvement
• Maintain a clean, compliant lab workspace with aseptic techniques
• Comply with safety policies and PPE handling
• Participate in CAPAs and cross-functional projects
• Provide training to new analysts

Skills

Attention to Detail

Technical Proficiency

Problem Solving

Communication

Teamwork

Compliance Mindset

Education

Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline

Job description

STAQ Pharma, Inc. in Columbus, OH is seeking a Laboratory Analyst to perform routine and advanced analytical and microbiological testing to support sterile drug product manufacturing in a 503B outsourcing facility.

You will execute USP methods and ensure all work complies with cGMP and ALCOA+ standards. The ideal candidate has a Bachelor’s degree in a relevant science and 3+ years in a regulated lab, with strong documentation and technical skills.