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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, microchallenges, 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, waterbath, 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, worksheets, and LIMS data, in compliance with cGDP, SLPs, STMs, and SOPs.
- Draft or create redlines (edits) of worksheets, SOPs, and STMs, managing the document change process from inception to completion.
- 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.
- Maintain housekeeping, organization, and laboratory safety, ensuring compliance and 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 participating in 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 ensure timely product release and regulatory compliance.
- Monitor laboratory work schedules and adherence to assignments to ensure timely release of in-process and final products.
- Ensure regulatory compliance for work performed and data released by the department.
- Contact vendors as delegated to make decisions on future media/materials and instrument/equipment purchases.
- 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 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 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
- Biological Sciences
- Laboratory Instrumentation
- Laboratory Methodologies
- Environmental Science
- Microsoft Office (Word, Excel)
- LIMS
- Aseptic Techniques
- Good Documentation Practices (cGDP)
- Good Laboratory Practices (SLP)
- Standard Operating Procedures (SOPs)
- Standard Test Methods (STMs)
- Current Good Manufacturing Practices (cGMP)
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 in microbiology or biological sciences
- Minimum of 1 general microbiological course with laboratory experience preferred
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.