Scientist I

An intermediate-level role in Quality Control Microbiology, responsible for microbiological test methods and instrumentation. The Scientist I also mentors and trains less experienced analysts.

Pay

Hourly range: $29.31 – $41.20. Final pay depends on experience, education, knowledge, skills, and abilities.

Benefits

• 401(k) plan with company contributions
• Paid vacation, holiday, and personal days
• Employee assistance program
• Medical, prescription drug, dental, and vision coverage

Responsibilities

• Understand department priorities and plan accordingly
• Perform peer review of data for accuracy, completeness, and conformance to specifications
• Keep supervisory personnel informed of relevant events, discrepancies, and out-of-limit conditions
• Articulate work-related issues clearly to management and peers
• Maintain knowledge of cGMPs, GLPs, and current compendial methods
• Teach or coordinate training modules and laboratory techniques for new analysts
• Assist in authoring basic investigative studies (OOS, OOT, OOL, invalid tests) and other documents
• Support senior personnel in projects, investigations, special testing, and project work
• Investigate deviations from SOP requirements and derive root causes
• Update SOPs or Methods of Analysis for microbiology test procedures
• Ensure adherence to safety policies and recommend improvements
• Maintain and calibrate equipment not handled by metrology or maintenance departments

Environmental Monitoring

• Schedule, initiate, coordinate, and perform routine and non-routine environmental monitoring
• Assess environmental conditions using various sampling methods for production areas and laboratory
• Recognize out-of-limit results and initiate OOL investigations
• Achieve ISO Class 5 gowning certification
• Process paperwork, LIMS input, and approvals for release by QA
• Use KabiTrack to record OOL events and change controls
• Assist with investigation of environmental OOL excursions
• Coordinate responses and actions for environmental issues
• Maintain laboratory areas, environmental chambers, and inventory of test media and reagents
• Complete microbial identification activities, including sub-culture, Gram staining, and culture maintenance
• Train manufacturing personnel in aseptic and gowning techniques
• Coordinate timely completion of routine testing
• Process and complete data collection for critical systems release
• Analyze data, recognize issues, and escalate unexpected results or trends

Finished Products Testing

• Schedule, initiate, coordinate, and perform routine testing of in-process, finished product, and raw materials
• Conduct environmental monitoring during bioburden and sterility testing (SKAN isolators)
• Complete microbial identification activities, including sub-culture, Gram staining, and culture maintenance
• Maintain testing equipment and coordinate requalification, preventive maintenance, and calibration
• Process paperwork, LIMS input, and approvals for release by QA
• Provide data for annual product reviews, investigational requests, and validation studies

Validations

• Validate microbiological test methods for new products, including APIs, in-process, and finished products
• Perform studies supporting new product introductions, method justifications, and validations
• Conduct routine testing of in-process and finished product samples for exhibit/process validation batches
• Review and approve testing results within the department
• Revise standard operating procedures (SOPs)
• Execute study protocols for production and laboratory method validations
• Support plant and lab equipment requalification studies
• Support Tech Transfer’s process validation protocols
• Perform microbiological testing for product process validation studies

Bacterial Filter Retention (BFR) Laboratory

• Author and execute BFR study protocols to validate sterilizing-grade filters
• Perform routine testing for validation activities, including viability, spike-flush, and filter compatibility studies
• Prepare microbial suspensions, media, and reagents as needed
• Monitor environmental conditions in the laboratory
• Review and approve testing results of peer work
• Assist with laboratory qualification and requalification studies
• Review and update SOPs related to BFR using Documentum
• Investigate nonconforming test results, determine root causes, and implement CAPAs
• Maintain laboratory equipment and coordinate preventive maintenance, calibration, and requalification