QC Analyst- Microbiology

The QC Analyst - Microbiology will support Quality Control laboratory operations by independently executing and reviewing routine in-process, drug substance, stability, facility monitoring, and microbiology test methods. This role will use laboratory instrumentation and computer systems to collect, record, and review data while ensuring compliance with SOPs, specifications, cGMP regulations, and data integrity requirements.

• Execute and review routine in-process, drug substance, stability, Environmental Monitoring, Critical Utilities, and facility monitoring test methods in a timely manner.
• Use laboratory instrumentation and computer systems to collect and record data, including systems such as LIMS, Softmax Pro, Charles River Endoscan, MODA, and Empower.
• Maintain laboratory operations, including cleaning, supply ordering, reagent preparation, stocking, waste disposal, and general lab upkeep.
• Demonstrate functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures.
• Work within a laboratory environment for extended periods while conducting testing, reviewing data, maintaining laboratory materials and instruments, and supporting other lab functions as required.
• Complete routine testing, special project testing, and protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with SOPs, specifications, and cGMP regulations.
• Exercise independent judgment within generally defined QC procedures and practices to troubleshoot issues and formulate solutions.
• Initiate, own, and author quality system events, including laboratory investigations, deviations, CAPAs, and change controls within an electronic Quality Management System.
• Draft studies and investigations of moderate scope and work on problems requiring review of identifiable factors.
• Author new SOPs and initiate changes to existing procedures.
• Participate in cross-functional teams.
• Train new QC Analysts on routine procedures and practices.
• Perform equipment maintenance and calibrations as required.
• Complete mandatory training within required time frames.
• Work overtime or an alternate shift as needed.
• Perform other duties as assigned.

• Bachelor’s or master’s degree in Life Sciences with relevant laboratory coursework required.
• 3-6 years of relevant experience preferred.
• Previous experience in a regulated environment preferred.
• QC Microbiology skill set preferred, including contamination control, endotoxin, bioburden, environmental monitoring, manufacturing clean rooms, aseptic technique, and critical utility systems.
• Knowledge of cGMP manufacturing.
• Knowledge of chemical, biological, and/or microbiological safety procedures.
• Understanding of laboratory instrumentation required.
• Ability to communicate effectively with managers and peers.
• Ability to read, write, and converse in English.
• Basic computer skills, including general use of word processing, spreadsheets, databases, training systems, performance management tools, and self-service platforms.
• Strong interpersonal skills with the ability to work effectively and efficiently in a team environment.
• Demonstrated eagerness to learn and continuously improve.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.