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About the Role

The BQ Analyst is responsible for performing routine and non-routine testing in support of manufacturing operations, including utility systems, sterilizer systems, raw materials, in-process product solutions, and final product solutions. This role adheres to safety, SOPs, STMs, specifications, cGMP, SLP, cGDP, and plant policies, working under direct supervision.

Responsibilities

Perform microbiological and biological testing according to SLPs, STMs and SOPs, including non-viable particulate, viable particulate, 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.
Utilize techniques such as 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, including non-viable particle counters, viable particle counters, UV-Vis spectrophotometer, FTIR, depyrogenation oven, steam sterilizer, pipettes, water bath, microscope, 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, and review/verify results of other personnel according to cGDP, SLPs, STMs and SOPs.
Utilize databases and software applications such as PharmSpec, MODA, Labware, Oracle, Microsoft Access, and Excel.
Draft or create redlines (edits) of worksheets, SOPs and STMs, including ownership of the document change process.
Draft and execute scientific protocols, low level and high level CAPA, laboratory investigations, or Over Alert Level Summary Reviews (OALSRs).
Complete daily room checks to verify laboratory cleanliness, reagent expiry, and instrument calibration dates.
Perform daily housekeeping, organization, and ensure laboratory safety, reconciling nonconformances.
Maintain and prepare media/materials in accordance with SOPs, including sterilization of liquid and hard goods items.
Provide support in resolving manufacturing problems, executing technical studies, and during laboratory investigations.
Identify and escalate questionable or inconsistent results to supervision or lead.
Participate in evaluating and clarifying problems and provide suggestions for resolution, including safety-related items.
Schedule, document, and provide technical training for new or cross-training laboratory personnel under supervision.
Monitor trainee work schedules to assure timely release of products and compliance with regulatory guidelines.
Monitor laboratory work schedules and adherence to assignments to assure timely release of products.
Ensure regulatory compliance for work performed and data released by the department.
Contact vendors as delegated to make decisions involving future media/materials and/or instrument/equipment purchases.
Evaluate analytical data to determine compliance with established STMs and SOPs and resolve routine analytical and quality problems.
Design experiments and develop new procedures to solve unique problems under direction.
Perform tasks outside of primary job duties on an as-needed basis, including cross-training and participation in special projects.

Requirements

Requires an understanding of laboratory instrumentation and methodologies including microbiology and environmental science(s).
Must maintain a high regard for detail, timeliness, and accuracy of all testing and associated documentation.
Must be able to read, understand, and execute instructions in basic laboratory procedures.
Must be able to use mathematics to solve routine problems and execute algebraic equations daily.
Must be able to perform tests quickly and efficiently without sacrificing accuracy, safety or quality.
Must be able to use Microsoft Office (Word, Excel) and have aptitude to learn internal systems including instrument/equipment software and electronic data management systems (e.g., LIMS).
Must recognize, communicate and appropriately respond to inconsistent and nonconformance results.
Must utilize good judgment in making decisions within limitations of recognized STMs and SOPs.
Must communicate effectively and proficiently at all levels both within and outside the plant, organizing communication logically and explaining technical information to non-technical individuals.
Must have demonstrated a high degree of personal maturity, reliability, and professional judgment.
Must have the ability to recognize, analyze and resolve analytical and quality problems.
Must be able to work flexible schedules, including overtime, holidays, and different shifts, in response to work demand.
Must demonstrate a willingness to assume additional responsibilities and solve departmental issues.
Must demonstrate a 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.

Skills

Microbiology
Environmental Science
Sterilization Science
Laboratory instrumentation
Laboratory methodologies
Microsoft Office (Word, Excel)
LIMS
Data management systems
Aseptic techniques
Pipetting
Plate reading
Gram staining
Microbial identification
Spectrophotometry
Microscopy

Location

Laboratory
Cleanroom environment
Manufacturing areas

Work Type

Full-time

Experience Level

Minimum of 4-6 years of relevant experience preferred

Education Level

Bachelor’s degree from an accredited college or university required.
Field(s) or specialty should include microbiology or biological sciences (Prefer a minimum of 1 general microbiological course with laboratory experience).

About the Company

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care.
Each product we make helps ensure patients receive the therapies they need without disruption.
When you work here, you become part of something bigger—a team dedicated to reliability and innovation.
Your work directly strengthens the healthcare supply chain and impacts patients nationwide.
We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
Join us and help shape the future of IV solutions.

Equal Opportunity

Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com.
We are committed to providing equal access and opportunities for all candidates.
Otsuka ICU Medical EEO Policy Statement
Know Your Rights: Workplace Discrimination is Illegal Poster
Otsuka ICU Medical CCPA Notice to Job Applicants