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

Role Summary

QC Analyst I/II - Microbiology (Sunday-Thursday). Perform routine quality control microbiology activities in support of product production and releases, with interaction across multiple internal departments and external entities. Ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.

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 or more years experience in a GMP or similarly regulated environment preferred
• Minimum of 25 hours/week gowning in classified areas (ISO 5, 7, 8, and CNC)
• 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)

Skills

• Environmental Monitoring (EM), Bioburden, Endotoxin, Growth Promotion testing
• Microbiological identification and mycoplasma testing coordination
• Laboratory operations and data handling
• Cross-functional collaboration and project planning

Education

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

Additional Requirements

• Physical requirements: 3-5 hours standing per day with frequent stooping and lifting; repetitive hand movements; occasional lifting up to 15 pounds
• Pre-Employment Testing: visual acuity screening and periodic re-testing for certain visual tests/assays
• Working environment: BL2 laboratory with PPE requirements; classified areas with full gowning