Quality Analyst

Company: GTT, LLC
Location: Carlsbad
Posted on: November 22, 2021

Job Description:

Quality Analyst Job Summary: * As a Quality Analyst III, you will help your direct manager to manage the comprehensive quality activities within Microbiology Lab, including managing to track and trending Microbiology testing data, managing timelines while ensuring the production environment is in a state of readiness for both testing, client audits, and regulatory inspections. * The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed. Job Description: * As a Quality Analyst III, you will support the daily operations of the Microbiology Lab and other functional groups. * You will need to manage and track the completion of the testing documentation, data entry, data review, and trending for Microbiology data in a timely manner. * Responsible for performing a wide variety of microbiological testing methods, but not limited to raw material testing, raw material qualification, and water testing as needed. * Proficient in performing, analyzing, and reviewing water sampling/testing, sterilization of equipment, growth promotion, endotoxin, microbial identification, biological indicator, and bioburden testing data. * Able to write and execute Bioburden Method Validation protocol, not limited to LAL Method Verification protocol. * Demonstrate proficiency in software usage, data analysis, and interpretation of testing data and trends. * Ensure that all of the required electronic data and documentation (raw data, testing records, and logbooks) are completed, reviewed, trended accurately, and entered in a timely manner. * Drive the testing data entries, tracking, and trending to completion. * Proficient in initiating, investigating, resolving, and completing event records in accordance with Client TRACKWISE. * Key personnel for reviewing and trending Microbial Identification data and its completion. * Operates and maintains lab equipment as required by SOPs and testing procedures * Actively support SOP revision processes, Item Specification, and other related documentation. * Proficient in leading protocol and special study executions. * Proficient in protocol and final report writing for special studies and projects. * Participate in scheduling team's weekly schedule and managing group meetings in the absence of Microbiology Management. * Acts as an SME for the junior analysts in routine and non-routine tasks. * Able to complete work independently and efficiently based on current SOPs, study protocol, regulatory guidance, and industry practice with no supervision. * Able to distinguish potential issues and professionally suggest potential solutions based on quality system guidelines and regulatory guidance. * Proactively assess current test method, current practice, and suggest process improvements to ensure regulatory guidance area followed and compliance area met. * Prioritize tasks to ensure that projects are completed by the assigned deadlines. * Support team building by participating in interviewing new talent. * Comply with company EH&S requirements. Promote a safety-first culture. Basics Qualifications: * Education Level and Languages Required * BS degree or higher in a Life Science discipline or equivalent. * BA/BS in a scientific discipline with 3 or more years of relevant experience * High School Diploma or Associate Degree in a Life Science discipline plus a minimum of 4-5 years of relevant experience. Professional Skills, Qualifications, and Experience * Previous experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, and electronic software is a must. * Previous knowledge/experience with automation, troubleshooting for machinery, equipment, and data integrity is a plus. * A strong understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals is a plus. * Previous understanding of the Aseptic Technique is a must. Previous knowledge/experience with Aseptic Gowning is a plus. Travel Requirements * None for daily tasks, except for off-site training as needed. Physical Requirements (PPE, lifting) * The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. * Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties, the employee is: * Constantly required to sit and reach to use computers and office/lab equipment * Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time * Occasionally required to lift up to fifty (50) pounds * Constantly required to view objects at close and distant ranges * Frequently required to communicate with others * The employee frequently works in a professional office environment and lab with computer equipment, machinery, tools, and moderate amounts of noise and activity. * Employees may occasionally be exposed to fumes, airborne particles, chemicals, vibration, and biohazardous materials. * The work environment is fast-paced and demanding. * This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. * The employee may be required to conduct off-shift, weekend, and overtime duties as assigned by the manager of the employee. Preferred Qualifications: * Previous experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, and electronic software is a must. * Previous knowledge/experience with automation, troubleshooting for machinery, equipment, and data integrity is a plus. * A strong understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals is a plus. * Previous understanding of the Aseptic Technique is a must. * Previous knowledge/experience with Aseptic Gowning is a plus.

Keywords: GTT, LLC, San Diego , Quality Analyst, Professions , Carlsbad, California