QC Analyst I/II -Microbiology

Role Summary

QC Analyst I/II in Microbiology performing routine quality control activities to support product production and releases. The role interfaces with multiple internal departments and may interact with contractors and suppliers to ensure regulatory compliance and accurate testing, trending, and reporting of 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; 1 or more years experience in a GMP or similarly regulated environment (preferred)
• This position requires a minimum of 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 necessary to perform data handling tasks (Microsoft Excel, Word, Outlook and Access)
• Good communication skills both written and verbal
• Experience with testing techniques such as Environmental Monitoring (EM), Bioburdn, Endotoxin, and Growth Promotion testing (preferred)

Education

• AS or BS degree in Microbiology or related field

Additional Requirements

• This position requires 3-5 hours of standing per day with frequent stooping and lifting. Also requires repetitive hand movements (micropipetting and keyboard use) for extended periods
• Occasional lifting/moving up to 15 pounds
• Pre-Employment Testing: visual acuity screening and periodic re-testing during employment for eligibility to perform certain visual tests/assays
• Environmental Conditions: primarily a laboratory environment with some office work; BL2 laboratory requiring PPE and full gowning in classified areas; exposure to chemicals and human tissue products