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. Interact with internal departments and external entities to ensure compliance with regulatory requirements through 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 gowned in classified areas; ISO 5, ISO 7, ISO 8, and CNC
• Proficiency with computer software for data handling (Microsoft Excel, Word, Outlook and Access)
• Good communication skills both written and verbal
• Experience with Environmental Monitoring, Bioburden, Endotoxin, and Growth Promotion testing preferred

Skills

• Handling biohazardous materials and chemicals; basic laboratory safety procedures
• Knowledge of cGMP and GLP regulations and compendial requirements (preferred)
• Ability to work in a fast-paced BL2 laboratory environment with PPE and gowning requirements

Education

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

Additional Requirements

• Physical: 3-5 hours standing per day with frequent stooping and lifting; repetitive hand movement; occasional lifting up to 15 pounds; visual acuity screening
• Environmental: primarily lab environment with some office time; exposure to chemicals and human tissue products