Biological Quality Analyst III

About the role

The BQ Analyst is responsible for performing routine and non-routine testing in support of all aspects of the manufacturing operations including 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), current good manufacturing practices (cGMP), standard laboratory practices (SLP), current good documentation practices (cGDP), and plant policies/guidelines. The BQ Analyst works under direct supervision or lead.

Responsibilities

• Perform microbiological and biological testing according to SLPs, STMs, and SOPs, including:
  • Non-viable particulate testing (liquid and air mediums)
  • Viable particulate testing (air medium)
  • Bioburden testing for pre-sterilized product and raw bulk drug using membrane filtration and/or direct plate inoculation
  • Bacterial Endotoxin (BET) testing
  • Heparin Potency testing
  • Environmental and utilities systems monitoring (e.g., floors, equipment, oil-free compressed gas)
  • Growth promotion of purchased and prepared media
  • Gram staining and organism culture creation and maintenance
  • Microbial identification and micro challenges
  • Non-viable particulate matter identification
• Utilize laboratory techniques such as serial diluting, pipetting, pour plating, handling and maintaining organism cultures, membrane filtration, direct plate inoculation, aseptic techniques, and plate reading
• Operate and maintain laboratory instruments and equipment, including:
  • Non-viable particle counters for liquid and air mediums (e.g., HIAC, CLIMET)
  • Viable particle counters for air medium (e.g., Surface Air Sampler (SAS))
  • UV-Vis spectrophotometer
  • Fourier-transform infrared spectrometer (FTIR)
  • Depyrogenation oven and steam sterilizer
  • Pipettes (fixed, variable)
  • Water baths (oil, water)
  • Compound light microscope and stereomicroscope
  • Centrifuge, barcode scanners, label printers
  • Stir/hot plates, timers/stopwatches
  • Laminar airflow hoods (LAF) and biosafety cabinets (BSC)
• Generate and maintain accurate manual (hardcopy) documents such as batch records and controlled worksheets, as well as electronic laboratory records of completed tasks
• Review and/or verify results of other laboratory personnel according to cGDP, SLPs, STMs, and SOPs
• Use laboratory information management systems (LIMS) such as PharmSpec, MODA, Labware, Oracle, Microsoft Access, and Excel (validated spreadsheets)
• Draft or create redlines (edits) of worksheets, SOPs, and STMs, including ownership of the document change process from inception to completion
• Assist in drafting and execution of 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 and solution expiry, and calibration dates of instruments and equipment
• Perform daily housekeeping, organization, and laboratory safety; ensure compliance and reconcile nonconformances through delegation or escalation
• Maintain and prepare media/materials in accordance with SOPs, including sterilization of liquid and hard goods items, decontamination, and other sterilization cycle types
• Support resolution of manufacturing problems, execution of technical studies, and laboratory investigations
• Identify and escalate questionable or inconsistent results to supervisor/manager or designee
• 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 the direction of the area supervisor or lead
• Monitor laboratory work schedules and adherence to assignments to ensure timely release of products and regulatory compliance
• Contact vendors to make decisions on media/materials and instrument/equipment purchases based on need and cost
• 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 the direction of the area supervisor or lead
• Perform tasks outside of 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 science
• Maintain high regard for detail, timeliness, and accuracy in all testing and documentation
• Ability to read, understand, and execute instructions in basic laboratory procedures
• Proficiency in using mathematics to solve routine problems and execute algebraic equations daily
• Ability to perform tests quickly and efficiently without sacrificing accuracy, safety, or quality
• Proficiency in Microsoft Office (Word, Excel) and aptitude to 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
• Utilize good judgment in making decisions within recognized STMs and SOPs
• Effective communication at all levels, both within and outside the plant; 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
• Willingness and ability to work flexible schedules, including overtime, holidays, and different shifts, in response to work demand
• Demonstrated 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

Minimum Qualifications, Education & Experience

• At least 18 years of age
• Bachelor’s degree from an accredited college or university in microbiology or biological sciences (preferred: minimum of 1 general microbiological course with laboratory experience)
• Minimum of 4–6 years of relevant experience preferred

Work Environment

• Work is performed in a laboratory, cleanroom environment, and other manufacturing areas
• Requires wearing specified personal protective equipment (PPE) and gowning attire (e.g., safety glasses, lab coat, cleanroom attire)
• Work involves handling microorganisms (as applicable), instruments, and equipment that may contain lasers or utilize steam and/or vacuum/pressurized systems
• May require sitting or standing for long periods depending on the activity
• Required to use a computer or touch screen to execute or enter work/data
• Ability to occasionally move and lift objects up to 25 pounds
• Travel typically less than 5% of the time