Biological Quality Analyst III

Otsuka ICU Medical•Austin, TX

10d•Hybrid

About The Position

The Biological Quality Analyst (BQ Analyst) is responsible for performing routine and non-routine testing to support all aspects of manufacturing operations. This includes testing of utility systems, sterilizer systems, incoming raw materials, in-process product solutions, and final product solutions. The role requires adherence to safety protocols, standard operating procedures (SOPs), standard test methods (STMs), specifications, current good manufacturing practices (cGMP), standard laboratory practices (SLP), current good documentation practices (cGDP), and plant policies/guidelines. The BQ Analyst will work under direct supervision or guidance from a lead.

Requirements

Understanding of laboratory instrumentation and methodologies, including microbiology and environmental science(s).
High regard for detail, timeliness, and accuracy of all testing and associated documentation.
Ability to read, understand, and execute instructions in basic laboratory procedures.
Ability to use mathematics to solve routine problems and execute algebraic equations daily.
Ability to perform tests quickly and efficiently without sacrificing accuracy, safety, or quality.
Ability to use Microsoft Office (Word, Excel) and learn internal systems including instrument/equipment software and electronic data management systems (e.g., LIMS).
Ability to recognize, communicate, and appropriately respond to inconsistent and nonconformance results.
Ability to use good judgment in making decisions within the limitations of recognized STMs and SOPs.
Effective and proficient communication skills at all levels, both within and outside the plant, organizing communication logically and explaining technical information to non-technical individuals.
Demonstrated high degree of personal maturity, reliability, and professional judgment.
Ability to recognize, analyze, and resolve analytical and quality problems.
Ability to work flexible schedules, including overtime, holidays, and different shifts, in response to work demand.
Willingness to assume additional responsibilities and solve departmental issues.
Thorough understanding of Microbiology, Environmental Science, or Sterilization Science and cause/effect relationships to better determine investigation results.
Must be at least 18 years of age.
Bachelor’s degree from an accredited college or university is required.
Field(s) or specialty should include microbiology or biological sciences (Prefer a minimum of 1 general microbiological course with laboratory experience).
Minimum of 4-6 years of relevant experience preferred.

Responsibilities

Perform microbiological and biological testing according to SLPs, STMs and SOPs, including non-viable particulate (liquid and air), viable particulate (air), bioburden, Bacterial Endotoxin (BET), Heparin Potency, environmental and utilities systems monitoring, growth promotion of media, gram staining, organism culture creation and maintenance, microbial identification, micro challenges, and non-viable particulate matter identification. Techniques include serial diluting, pipetting, pour plating, handling and maintaining organism cultures, membrane filtration, direct plate inoculation, aseptic techniques, and plate reading.
Utilize and maintain laboratory instruments and equipment such as non-viable particle counters, viable particle counters, UV-Vis spectrophotometer, FTIR, depyrogenation oven, steam sterilizer, pipettes, water bath, microscopes, centrifuge, barcode scanners, label printers, stir/hot plates, timers/stopwatches, laminar airflow hoods (LAF), and biosafety cabinets (BSC).
Generate and maintain accurate manual and electronic laboratory records, including batch records and controlled worksheets, adhering to cGDP, SLPs, STMs, and SOPs. Utilize databases and software applications like PharmSpec, MODA, LIMS (Labware, Oracle), Microsoft Access, and Excel.
Draft or create redlines (edits) for worksheets, SOPs, and STMs, potentially managing the document change process. Draft and execute scientific protocols, CAPA, and laboratory investigations or Over Alert Level Summary Reviews (OALSRs).
Complete daily room checks to verify laboratory cleanliness, reagent expiry, and instrument calibration. Maintain daily housekeeping, organization, and laboratory safety, ensuring compliance and escalating nonconformances.
Maintain and prepare media/materials according to SOPs, including sterilization of liquid and hard goods items and various sterilization cycle types.
Support the resolution of manufacturing problems, execution of technical studies, and laboratory investigations. Identify and escalate questionable or inconsistent results to supervisors/managers or lead laboratory technicians, participating in problem evaluation and suggesting resolutions.
Under direction, schedule, document, and provide technical training for new or cross-training laboratory personnel, monitoring work schedules to ensure timely product release and compliance.
Monitor laboratory work schedules and adherence to assignments to ensure timely release of in-process and final products, ensuring regulatory compliance.
Contact vendors as delegated to make decisions on media/materials and instrument/equipment purchases based on need and costs.
Evaluate analytical data to determine compliance with STMs and SOPs, and resolve routine analytical and quality problems.
Design experiments and develop new procedures to solve unique problems under supervision.
Perform tasks outside of primary job duties on an as-needed basis, including cross-training in Environmental Quality laboratories/functions and participation in special projects.