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.

• 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 as 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 Pharm Spec, 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 escape 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…