Quality Control Microbiology Specialist (Pharmaceutical Microbiology)

Location: Rensselaer, New York, United States; onsite role. Schedule: Monday–Friday, 8:00 a.m.–4:30 p.m.

Salary: $67,400–$110,000 annually.

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Serve as a technical resource and subject matter expert for QC microbiology operations, methods, and testing programs.
• Perform and support microbiological testing related to clean room monitoring, utility monitoring, raw materials, products, endotoxin, sterility, and bioburden.
• Evaluate and implement microbiological methods, laboratory procedures, equipment, software applications, and reporting tools.
• Lead laboratory studies, investigations, deviations, non-conformances, root cause analyses, and technical assessments.
• Initiate and close Change Controls, CAPAs, deviations, document revisions, and other quality system records.
• Support audits and regulatory inspections, monitor laboratory KPIs, and implement improvements to compliance, data quality, and operational efficiency.

Requirements

• Bachelor’s degree in Biology, Microbiology, or a related field, plus 2+ years of relevant experience.
• Advanced knowledge of pharmaceutical microbiology and microbiological testing methods.
• Knowledge of cGMP regulations, data integrity, regulatory guidance, compendial requirements, and laboratory compliance.
• Experience with laboratory investigations, root cause analysis, Change Control, CAPA, deviation management, and quality systems.
• Experience with electronic quality management systems, laboratory software, Microsoft Office, LIMS, LMS, and deviation management systems.
• Strong analytical, technical writing, and problem-solving skills.

Nice to have

• Experience with regulatory inspections and audit readiness.
• Experience in biologics, sterile manufacturing, or gene therapy environments.
• Experience implementing laboratory methods, instrumentation, software systems, or process improvements.
• Leadership experience in cross-functional projects and continuous improvement initiatives.

Culture & Benefits

• Inclusive workplace and equal employment opportunity environment.
• Comprehensive rewards package may include bonuses, equity, retirement benefits, 401(k) matching, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where required.