Biological Quality Analyst III

Position Summary 

The BQ Analyst is responsible for performing routine and non-routine testing in support of all aspects of the manufacturing operations including but not limited to the utility systems, sterilizer systems, incoming raw materials, in-process product solutions and final product solutions while adhering to safety, standard operating procedures (SOPs), standard test methods (STMs) and 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 supervisor or lead.

Essential Duties & Responsibilities

• Perform microbiological and biological testing according to SLPs, STMs and SOPs. Test types (when applicable) include but are not limited to non-viable particulate (liquid and air mediums), viable particulate (air medium), bioburden for pre-sterilized product and raw bulk drug utilizing membrane filtration and/or direct plate inoculation, Bacterial Endotoxin (BET), Heparin Potency, environmental and utilities systems monitoring (e.g., floors, equipment, oil-free compressed gas), growth promotion of purchased and prepared media, gram staining, organism culture creation and maintenance, microbial identification, micro challenges, and non-viable particulate matter identification. Techniques utilized include but are not limited to serial diluting, pipetting, pour plating, handling and maintaining organism cultures, membrane filtration and direct plate inoculation, aseptic, and plate reading.


• Utilization and maintenance of laboratory instruments and equipment in support of routine and non-routine testing such according to SLPs, STMs, and SOPs. Instruments/equipment (when applicable) include but are not limited to 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, steam sterilizer, pipettes (e.g., fixed, variable), water bath (e.g., oil, water), compound light microscope, 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 other controlled worksheets and electronic laboratory records of tasks completed and review and/or verify the results of other laboratory personnel according to cGDP, SLPs, STMs and SOPs. Generation and maintenance of such records include compliant utilization of databases and software applications such as PharmSpec, MODA or other laboratory information management system (LIMS) such as Labware, Oracle, Microsoft (e.g., Access), and Excel (e.g., validated spreadsheets).


• Draft or create redlines (edits) of worksheets, SOPs and STMs with. Under the direction of supervision or lead, includes ownership from inception to completion of the corresponding document change process (as applicable). Includes drafting and execution of scientific protocols, low level and high level CAPA and/or laboratory investigations or Over Alert Level Summary Reviews (OALSRs), as applicable.


• Complete daily room check to verify laboratory cleanliness, expiry of reagents and solutions, calibration dates of instruments and equipment (as applicable). Responsible for daily housekeeping, organization, and laboratory safety. Ensures compliance and reconciles any nonconformances through delegation or escalation (as applicable).


• Maintain and prepare media/materials in accordance with SOPs including sterilization of liquid and hard goods items. Includes decontamination and other sterilization cycle types as applicable.


• Provide support in the resolution of manufacturing (production) problems, the execution of technical studies, and during laboratory investigations. Identify and escalate questionable or inconsistent results to the supervisor/manager or other designee such as lead laboratory technician(s). Participate in evaluating and clarifying problems and provide suggestions for resolution. Includes safety related items. 


• Under the direction of the area supervisor or lead, schedule, document, and provide technical training for new or cross-training laboratory personnel. Includes monitoring the trainee’s work schedule (as directed by supervisor or lead) to assure timely release of products and compliance with regulatory guidelines for work performed and data released by the department.


• Monitor the laboratory work schedules (including other scientific technicians) and adherence to laboratory assignments to assure timely release of products (both in-process and final product). Ensures 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 based on need and costs.


• 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 from the area supervisor or lead.


• Perform tasks outside of primary job duties on an as-needed basis or per business/departmental needs. This will include, but is not limited to, cross-training in Environmental Quality laboratories/functions and participation in special projects.

Knowledge & Skills

• 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 (i.e. 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. The individual is required to organize communication in a logical manner and explain 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. 

Minimum Qualifications, Education & Experience 

• 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.

Work Environment

• Work is performed in a laboratory as well as cleanroom environment and other manufacturing areas; work is performed while wearing specified personal protective equipment (PPE) and other gowning attire as applicable (e.g., safety glasses, lab coat, cleanroom attire). 


• Work is performed with microorganisms (as applicable) as well as instruments and equipment which may contain lasers or utilize steam and/or vacuum/pressurized. 


• While performing the duties of this job, the employee may be required to sit or stand for long periods of time depending on the given activity.


• Required to use a computer or touch screen to execute or enter work/data.


• Must be able to occasionally move and lift objects of up to 25 pounds (lbs.).


• Typically requires travel less than 5% of the time