QC Analyst I/II -Microbiology (Sunday-Thursday)

Role Summary

QC Analyst I/II -Microbiology (Sunday-Thursday)

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 preferred; 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

Skills

• Handling biohazardous materials and chemicals
• Basic laboratory safety procedures
• Knowledge of cGMP and GLP regulations and compendial requirements (preferred)
• Proficiency with Microsoft Excel, Word, Outlook and Access
• Good written and verbal communication skills
• Experience with Environmental Monitoring, Bioburden, Endotoxin, and Growth Promotion testing (preferred)

Education

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

Additional Requirements

• This position requires 3-5 hours of standing per day with frequent stooping and lifting; occasional lifting up to 15 pounds
• Repetitive hand movements (micropipetting, keyboard use) for extended periods
• Pre-Employment Visual Acuity screening and periodic re-testing