QC Analyst I/II -Microbiology

Role Summary

QC Analyst I/II - Microbiology performs routine quality control microbiology activities in support of product production and releases, ensuring compliance with applicable regulatory requirements through testing, trending, and reporting results. The role interacts with multiple internal departments and may interact with external entities such as contractors and suppliers.

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.)
• Participates, contributes and adds value in cross-functional settings. Collaborates and communicates appropriately in all situations
• Independently plans to execute projects and knows when to include others. Looks for 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 computer software for data handling and reports (Microsoft Excel, Word, Outlook and Access)
• Good written and verbal communication skills
• Experience with Environmental Monitoring, Bioburdent, Endotoxin, and Growth Promotion testing (preferred)

Skills

• Attention to detail and strong troubleshooting
• Effective collaboration and cross-functional communication
• Project planning and time management

Education

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

Additional Requirements

• Physical: 3-5 hours standing per day with frequent stooping and lifting; repetitive hand movements; occasional lifting up to 15 pounds
• Environmental: laboratory BL2 environment with PPE requirements; potential exposure to chemicals and human tissue products
• Pre-Employment Testing: visual acuity screening and periodic re-testing