QC Analyst I/II -Microbiology

Role Summary

QC Analyst I/II - Microbiology responsible for performing routine quality control microbiology activities to support product production and releases, including environmental monitoring, microbiological testing, and collaboration with multiple internal departments. Requires adherence to regulatory requirements and participation in quality systems programs. Schedule and training period outlined in description.

Responsibilities

• Perform and read environmental monitoring, critical utilities and personnel testing samples
• Perform and support microbiological testing, such as plate count enumeration, critical utilities monitoring, endotoxin testing, environmental monitoring, bioburden, and growth promotion
• Perform raw material, intermediate and non-routine testing
• Perform general laboratory maintenance activities
• Prepare and send out samples for microbiological identification and/or mycoplasma testing
• Assist in revising SOPs
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood
• Participate in high-level quality systems programs (Excursions, deviations CAPA, etc.)
• Collaborate and communicate appropriately in cross-functional settings
• Independently plan to execute projects and seek ways to reduce errors and costs
• Takes ownership for meeting all deliverables

Qualifications

• AS or BS degree in Microbiology or related field; 1+ years experience in a GMP or similarly regulated environment preferred
• Minimum 25 hours/week gowned in classified areas; ISO 5, ISO 7, ISO 8, and CNC
• Handling biohazardous materials and chemicals; basic laboratory safety procedures
• Knowledge of cGMP and GLP regulations and compendial requirements, preferred
• Proficiency with software for data handling and reports (Microsoft Excel, Word, Outlook, Access)
• Good written and verbal communication skills
• Experience with testing techniques such as Environmental Monitoring, Bioburden, Endotoxin, and Growth Promotion testing preferred
• Physical ability to stand 3-5 hours/day, frequent stooping and lifting; occasional lifting up to 15 pounds
• Pre-Employment visual acuity screening and periodic re-testing required
• Laboratory environment exposure to chemicals and human tissue products; adherence to PPE and gowning requirements

Skills

• Environmental Monitoring (EM)
• Bioburden and Endotoxin testing
• Growth Promotion testing
• Mycoplasma testing and microbiological identification
• SOP revision and quality systems participation
• Cross-functional collaboration and project planning

Education

• AS or BS degree in Microbiology or related field (preferred)

Physical/Environmental Requirements

• 3-5 hours of standing per day; repetitive hand movement
• Occasional lifting up to 15 pounds
• Laboratory BL2 environment with PPE and full gowning in classified areas
• Exposure to disinfectants and human tissue products