Occupational Health Nurse

Position Summary

The BQ Analyst is responsible for performing routine and non‑routine testing in support of all aspects of manufacturing operations, including utility systems, sterilizer systems, incoming raw materials, in‑process product solutions and final product solutions. Work is performed in accordance with safety guidelines, 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.

Essential Duties & Responsibilities

• Perform microbiological and biological testing according to SLPs, STMs and SOPs. Test types include non‑viable particulate (liquid and air), viable particulate (air), bioburden, bacterial endotoxin (BET), heparin potency, environmental and utilities monitoring, growth promotion, gram staining, organism culture creation and maintenance, microbial identification, micro‑challenges, and non‑viable particulate matter identification; techniques include serial diluting, pipetting, pour plating, membrane filtration, direct plate inoculation, aseptic handling and plate reading.
• Utilize and maintain laboratory instruments and equipment for routine and non‑routine testing, such as non‑viable particle counters (HIAC, CLIMET), viable particle counters (Surface Air Sampler), UV‑Vis spectrophotometer, FTIR, depyrogenation oven, steam sterilizer, pipettes, water baths, compound light and stereo microscopes, centrifuge, barcode scanners, label printers, stir/hot plates, timers/stopwatches, laminar airflow hoods and biosafety cabinets.
• Generate and maintain accurate manual (hard‑copy) documents (batch records, controlled worksheets) and electronic laboratory records; review and verify results of other laboratory personnel in compliance with cGDP, SLPs, STMs and SOPs. Use databases and software such as PharmSpec, MODA, LIMS (Labware, Oracle, Microsoft Access) and validated Excel spreadsheets.
• Draft or edit worksheets, SOPs and STMs, managing the document change process from inception to completion; develop scientific protocols, low‑ and high‑level CAPA, laboratory investigations and Over‑Alert Level Summary Reviews (OALSRs) as needed.
• Complete daily room checks to verify laboratory cleanliness, reagent expiry, and instrument calibration dates; perform daily housekeeping, organization and laboratory safety, and reconcile any non‑conformances.
• Maintain and prepare media/materials per SOPs, including sterilization of liquids and hard goods, decontamination, and other sterilization cycles.
• Support resolution of manufacturing (production) problems, execute technical studies, and assist with laboratory investigations; identify and escalate questionable or inconsistent results.
• Participate in problem evaluation, provide suggestions for resolution, and address safety‑related items.
• Under supervision, schedule, document and provide technical training for new or cross‑trained laboratory personnel; monitor trainee work schedules to ensure timely product release and regulatory compliance.
• Monitor laboratory work schedules (including other scientific technicians) and adherence to assignments to assure timely release of in‑process and final products; ensure regulatory compliance for work performed and data released.
• Contact vendors, as delegated, to make decisions regarding media/materials or instrument/equipment purchases based on need and cost.
• Evaluate analytical data for compliance with established STMs and SOPs; resolve routine analytical and quality problems.
• Design experiments and develop new procedures to solve unique problems under direction of the area supervisor or lead.
• Perform tasks outside primary duties as needed, including cross‑training in Environmental Quality laboratories/functions and participation in special projects.

Knowledge & Skills

• Understanding of laboratory instrumentation and methodologies, including microbiology and environmental sciences.
• High regard for detail, timeliness, and accuracy of testing and associated documentation.
• Ability to read, understand, and execute basic laboratory procedures.
• Proficiency with mathematics to solve routine problems and perform algebraic calculations daily.
• Capability to perform tests quickly and efficiently without sacrificing accuracy, safety, or quality.
• Experience with Microsoft Office (Word, Excel) and aptitude to learn internal systems, instrument/software, and electronic data management systems (e.g., LIMS).
• Skill in recognizing, communicating, and appropriately responding to inconsistent or non‑conforming results.
• Good judgment in decision‑making within the limits of recognized STMs and SOPs.
• Effective communication at all organizational levels; ability to explain technical information to non‑technical individuals.
• Demonstrated personal maturity, reliability, and professional judgment.
• Ability to recognize, analyze, and resolve analytical and quality problems.
• Flexibility to work overtime, holidays, and varying shifts as required by work demand.
• Willingness to assume additional responsibilities and address departmental issues.
• Thorough understanding of microbiology, environmental science, or sterilization science and related cause/effect relationships.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor’s degree from an accredited college or university; field should include microbiology or biological sciences (prefer a minimum of one general microbiology course with laboratory experience).
• Minimum of 4–6 years of relevant experience preferred.

Work Environment

• Work performed in laboratory, cleanroom, and other manufacturing areas while wearing required personal protective equipment (PPE) and gowning (e.g., safety glasses, lab coat, cleanroom attire).
• Exposure to microorganisms and instruments that may contain lasers or utilize steam, vacuum, or pressurized systems.
• May require prolonged sitting or standing depending on activity.
• Use of computer or touch screen to enter data.
• Occasional lifting of objects up to 25 lb.