Microbiology Quality Control Analyst

Role Overview:

• Support the Quality Control (QC) laboratory by performing biochemical, microbiological, and general chemical testing on in-process and final product samples
• Ensure all testing is executed in compliance with applicable procedures, standards, and GMP regulations
• Serve as a shift leader, working primarily independently while maintaining strong communication with cross-functional teams
• Demonstrate high attention to detail, organizational leadership, critical thinking, and technical writing capabilities

Key Responsibilities:

• Perform analytical testing in accordance with GMP regulations while maintaining compliance with environmental, health, and safety (EHS) standards
• Conduct biochemical, microbiological, and chemical testing for raw materials, utilities, in-process, and final product samples
• Perform peer review of laboratory data to ensure accuracy and compliance
• Utilize electronic systems (LIMS, MES, LES, Empower, TrackWise, etc.) for testing execution and documentation
• Maintain laboratory operations, including sample management, reagent preparation, and instrument calibration/standardization
• Complete and support document revisions (SOPs, methods, protocols)
• Maintain training compliance and support onboarding/training of new laboratory personnel
• Participate in continuous improvement initiatives and process optimization
• Execute CAPAs as required within the QC organization
• Maintain an audit-ready laboratory environment and support internal and regulatory inspections
• Contribute to functional laboratory meetings and provide technical input
• Work independently on alternative shifts while effectively communicating with operations and cross-functional teams

Required Skills & Experience:

• Bachelor’s degree in Chemistry, Microbiology, or a related scientific field
• Minimum of 3 years of microbiology testing experience (bioburden, endotoxin, environmental monitoring)
• Strong knowledge of current Good Manufacturing Practices (cGMP) within a QC laboratory environment
• Ability to identify process or system gaps and support resolution efforts
• Familiarity with compendial standards (USP, EP, JP, etc.) for QC testing
• Ability to read and interpret SOPs, work instructions, test methods, and protocols

Compensation:

$32-35/hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.