Quality Control - Microbiologist II
10 days ago
San Antonio
Job DescriptionDescription: TITLE: Quality Control – Microbiologist II REPORTS TO: Manager, Environmental Monitoring & Microbiology LOCATION: San Antonio, Texas (Onsite) The Company Velocity Bioworks is a U.S.-based biopharma CDMO headquartered in San Antonio, Texas supporting funded programs as they move from development into manufacturing for clinical trials. We collaborate with sponsors who are past exploration and are ready to apply discipline, structure, and technical rigor to development, analytics, and manufacturing. Velocity is built to accelerate speed to clinic through aligned execution. Our work focuses on translating defined program goals into scalable manufacturing processes and robust analytical strategies. These activities are designed to support near-term clinical timelines while meeting quality requirements. We operate where quality and execution directly influence clinical progress. Position Summary The Quality Control – Microbiologist II will support the Environmental Monitoring (EM) and Microbiology programs within the Quality Control (QC) department. The candidate will be responsible for conducting environmental and personnel monitoring activities; operating sampling and testing equipment; adhering to and supporting improvements to quality documents within the quality management system; and performing day-to-day microbiological activities within the manufacturing facility, including cleanroom environments, warehouse facilities, and laboratory spaces as needed. This individual will initiate and conduct EM and QC testing, author, review, and revise GMP documentation, adhere to GMP operations, and contribute to initiatives that build infrastructure, processes, and capabilities across our state-of-the-art biomanufacturing facilities in San Antonio, TX. The ideal candidate has keen attention to detail, is highly organized, and possesses strong written and verbal communication skills. This individual must exhibit good time-management skills, take initiative, and thrive in a fast-paced, dynamic biotech environment. She/he/they must be versatile and adapt to rapid change with a strong desire to make a significant impact at Velocity Bioworks . Key Responsibilities • Execute environmental and personnel monitoring sampling and testing in accordance with approved procedure., • Perform microbiological laboratory support activities, including Gram staining and basic microbial identification, in accordance with approved procedures., • Prepare, package, and coordinate shipment of environmental monitoring samples and plates to external contract laboratories when required, ensuring chain of custody and sample integrity are maintained., • Contribute to achieving department metrics, timelines, and daily operational activities., • Perform routine EM-related tasks with minimal supervision and complex tasks with moderate direction., • Identify and escalate OOS results, trends, or operational concerns in a timely manner., • Support microbiological investigations, including OOS and EM excursions, through data review, documentation, and technical input., • Author, review, and revise technical documents, protocols, and investigation records., • Support qualification and requalification activities for classified areas and controlled environments., • Assist manufacturing and facility departments in solving microbiology-related deviation issues., • Assist in the creation, implementation, and administration of microbiology-based programs., • Participate in activities associated with aseptic process simulations (APS/media fills)., • Support Change Control and CAPA activities, including initiation, impact assessment, implementation and closure of assigned actions., • Support the initiative of streamlining data entry, analysis, and reporting of microbiological data., • Propose alternative solutions or process improvement and obtain appropriate approvals prior to implementation., • Participate in internal audit discussions and collaborate with cross-functional teams to address microbiological requests., • Participate in technical discussions and problem-solving activities with external entities (i.e., contract test labs) to support issue resolutions., • BS/BA in Life Sciences, or a related field, Biology, Microbiology preferred, • 2+ years of relevant experience in a GMP pharmaceutical environment Skills & Competencies • Ability to work effectively in a dynamic, fast-paced environment, • Ability to collaboratively work with multiple departments to ensure efficient and timely completion of assigned tasks., • Strong authorship with the ability to critically review executed documents and protocols., • Ability to prepare clear, accurate, and effective communications to management., • Must be action-oriented, problem-solving, with strong organizational, planning, conflict management, and analytical thinking., • Ability to work independently on routine tasks and moderate direction to complete complex tasks. Work is self-directed., • Confident in making decisions for minor issues., • Contributes to achieving goals within the workgroup., • Knowledge of aseptic manufacturing processes., • Excellent verbal and written communication skills, • Self-motivation with strong organizational skills to manage workload independently, providing appropriate communication and escalation to ensure timely resolution and support., • Understanding of microbiological test methods, method validation, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CTOs., • Knowledge of EM programs, investigation, and data trending., • Ability to make sound technical judgements related to microbiological methods., • Develop, guide, and support strategies on how to achieve actions and develop metrics to measure the strategy., • Ability to resolve conflicts or problems using tact, diplomacy, and composure., • Strong organizational agility with the ability to manage multiple priorities with exceptional organizational and time management skills., • Experience in biopharmaceutical manufacturing, cell and gene therapy experience a plus. Physical Requirements & Working Environment • Must be able to become qualified for entry into ISO-classified cleanrooms. This includes the ability to wear full aseptic gowning and remain in a cleanroom environment for extended periods., • Regularly required to sit, stand, and walk for extended periods. Must have the manual dexterity to use computer systems and the ability to occasionally lift or move up to 20 pounds., • Specific vision abilities required include close vision, color vision, and the ability to adjust focus for document and sample review., • Work is performed on-site in an environmentally controlled CGMP-regulated biologics facility. The setting includes a combination of office, laboratory, and manufacturing environments with moderate noise levels., • Flexibility in working hours is required to align with manufacturing schedules. This may include occasional early mornings, late evenings, and weekend support as needed. Notice to Third Party Agencies: Velocity Bioworks does not accept unsolicited resumes from recruiters or employment agencies. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement and approved engagement request with Velocity Bioworks, Velocity Bioworks reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Velocity Bioworks is proud to be an EEO/AAP Employer. Velocity Bioworks encourages protected veterans, individuals with disabilities, and applicants from all backgrounds to apply. Velocity Bioworks ensures nondiscrimination in all programs and activities in accordance with Title VI of the Civil Rights Act.