SCIENTIST I

Location: Melrose Park, IL • Contract • On-Site

About the role

A Scientist I in Quality Control Microbiology is responsible for an intermediate level of expertise of microbiological test methods and instrumentation. A Scientist I participates in the mentoring and training of less experienced analysts in the group. The QC Microbiology department contains five main functional groups: Environmental Monitoring, Finished Products Testing, Validations, Bacterial Filter Retention (BFR) Laboratory, and Microbial ID Laboratory.

Responsibilities

• Ensure compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.
• 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 impacting operations and performance, including discrepancies and out-of-limit conditions.
• Articulate work-related issues clearly and effectively 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 necessary documents for the Quality Control Microbiology department (not applicable for ID Lab except invalid runs).
• 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-related policies and recommend improvements.
• Maintain and calibrate equipment not handled by metrology or maintenance departments.
• Perform other duties as assigned.
• Maintain current training compliance through KabiLift.

Environmental Monitoring

• Schedule, initiate, coordinate, and perform routine and non-routine environmental monitoring according to established procedures.
• Assess environmental conditions using various methods to sample environment, water systems, compressed gas, and personnel in production areas and microbiology 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 Critical Systems.
• Demonstrate solid working knowledge of KabiTrack and record OOL events and change controls.
• Assist with investigation of environmental OOL excursions.
• Coordinate responses and actions associated with environmental issues.
• Maintain good housekeeping of laboratory areas, environmental chambers, and inventory of test media and reagents.
• Complete activities required for microbial identification, including sub-culture, Gram staining, and proper culture maintenance.
• Assist in training manufacturing personnel in aseptic and gowning techniques.
• Coordinate timely completion of routine testing.
• Process and complete data collection for all critical systems release.
• Analyze data, recognize issues, and escalate unexpected results or trending.

Finished Products Testing

• Schedule, initiate, coordinate, and perform routine testing of in-process, finished product, raw material, and component samples.
• Conduct environmental monitoring during bioburden and sterility testing (SKAN isolators).
• Assist with microbial identification activities, including sub-culture, Gram staining, and proper culture maintenance.
• Maintain testing equipment and coordinate requalification, preventative 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 all new products, including APIs, in-process, and finished products.
• Perform studies supporting new products, method justifications for new stoppers and vials, PFBB validation, raw material bioburden/Bacterial Endotoxin method validations, and finished products.
• Conduct routine testing of in-process and finished product samples on exhibit/process validation batches.
• Review and approve testing results of procedures performed in the department.
• Revise standard operating procedures (SOP).
• Execute study protocols to validate production and laboratory methods.
• 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 per established procedures to validate sterilizing grade filters used in manufacturing aseptic fill process.
• Perform routine testing of 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 standard operating procedures related to BFR using Documentum.
• Assist in investigating nonconforming test results for validation impact, root cause, and CAPA.
• Maintain laboratory equipment and coordinate preventative maintenance, calibration, and requalification.

Microbial ID Laboratory

• Complete all microbial identification activities for in-house isolates using the Microbial Identification system, including sub-culture, Gram staining, and proper culture maintenance.
• Maintain accurate records of all work completed.
• Promptly report data discrepancies and equipment issues to supervisor/manager.
• Train new departmental personnel in standard operating procedures and training modules for the MALDI ID System.
• Collaborate to troubleshoot the MALDI ID system by applying problem-solving skills and sourcing literature or vendors as necessary.
• Support all scheduled vendor PM/Calibration activities.
• Maintain inventory of reagents/materials needed for microbial identifications and keep accurate records of IDs performed in-house.
• Follow up to send unidentified microbial IDs for further testing.

Requirements

• Bachelor of Science degree in a biological science with 1-3 years of progressive laboratory experience.
• For positions in the MALDI ID Laboratory, previous experience with microbial identification using this system is desirable.
• Excellent verbal and written communication skills.
• Strong planning and organizational skills.
• Must successfully execute requirements to achieve ISO 5 environment gown certification as required (Environmental Monitoring Group).

Pay

$19–$22/hour depending on experience.