Biological Quality Analyst III

ICU Medical•Austin, TX

9d•Hybrid

About The Position

The Biological Quality Analyst (BQ Analyst) is responsible for performing routine and non-routine testing in support of all aspects of manufacturing operations. This includes testing of 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), 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 supervision or a lead. Essential Duties & Responsibilities include performing microbiological and biological testing, utilizing and maintaining laboratory instruments and equipment, generating and maintaining accurate manual and electronic laboratory records, drafting or creating redlines of worksheets, SOPs, and STMs, and participating in the document change process. The role also involves drafting and executing scientific protocols, CAPA, laboratory investigations, and Over Alert Level Summary Reviews (OALSRs). Daily tasks include room checks for laboratory cleanliness, reagent expiry, and instrument calibration, as well as maintaining laboratory safety and organization. The BQ Analyst supports the resolution of manufacturing problems, execution of technical studies, and laboratory investigations, identifying and escalating questionable results. They may also provide technical training, monitor laboratory work schedules, and contact vendors for media/materials or instrument/equipment purchases. The role involves evaluating analytical data for compliance, designing experiments, and developing new procedures. Tasks outside primary duties, including cross-training and special projects, may be required.

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 (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 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.
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).

Nice To Haves

Minimum of 4-6 years of relevant experience preferred.

Responsibilities

Perform microbiological and biological testing according to SLPs, STMs and SOPs.
Test types include non-viable particulate (liquid and air mediums), viable particulate (air medium), bioburden for pre-sterilized product and raw bulk drug, Bacterial Endotoxin (BET), Heparin Potency, environmental and utilities systems monitoring, growth promotion of purchased and prepared media, gram staining, organism culture creation and maintenance, microbial identification, micro challenges, and non-viable particulate matter identification.
Utilize techniques such as serial diluting, pipetting, pour plating, handling and maintaining organism cultures, membrane filtration and direct plate inoculation, aseptic techniques, and plate reading.
Utilize and maintain laboratory instruments and equipment in support of routine and non-routine testing.
Generate and maintain accurate manual (hardcopy) documents such as batch records and other controlled worksheets and electronic laboratory records of tasks completed.
Review and/or verify the results of other laboratory personnel according to cGDP, SLPs, STMs and SOPs.
Utilize 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.
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.
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.
Under the direction of the area supervisor or lead, schedule, document, and provide technical training for new or cross-training laboratory personnel.
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.
Cross-train in Environmental Quality laboratories/functions and participate in special projects.