QC Analyst I/II -Microbiology

Role Summary

Perform routine quality control microbiology activities in support of product production and releases. The position interacts with internal departments, including Apligraf Production, PuraPly Production, Quality Assurance, Validation, Calibration, Materials, and Logistics, and may interact with external entities such as contractors and suppliers. The QC Analyst I/II performs a wide variety of routine activities to 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

• Required: AS or BS degree in Microbiology or related field
• Required: 1 or more years experience in a GMP or similarly regulated environment
• Preferred: Experience with 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; preferred
• Proficiency with computer software for data handling and reporting (Microsoft Excel, Word, Outlook, Access)
• Good communication skills, both written and verbal
• Preferred: Experience with Environmental Monitoring (EM), Bioburden, Endotoxin, and Growth Promotion testing

Skills

• Laboratory testing techniques and instrumentation related to microbiology
• Data analysis, trend analysis, and reporting
• Interpersonal communication and cross-functional collaboration

Education

• AS or BS degree in Microbiology or related field

Additional Requirements

• Physical Requirements: 3-5 hours of standing per day with frequent stooping and lifting; repetitive hand movements (micropipetting and keyboard use); occasional lifting up to 15 pounds
• Environmental Conditions: Laboratory environment (BL2) with portions in an office; use of PPE and gowning in classified areas; exposure to chemicals and human tissue products
• Pre-Employment Testing: Visual acuity screening and periodic re-testing for certain visual standards