Team Lead, QC Microbiology

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us Position: Team Lead, QC Microbiology Location : Phoenix, AZ *** 3rd Shift- 10pm.- 6:30am.*** Education and Experience Bachelor’s Degree or associate degree, particularly in Microbiology or Science related field, strongly preferred. High School diploma or equivalent required. 3+ years relevant work experience required, preferably in a manufacturing environment with cGMP requirement. An equivalent combination of education/experience may substitute. Required Competencies: Knowledge, Skills, and Abilities Advanced knowledge, experience, and/or ability of the following: cGMP/GXP documentation skills. Hands-on experience with various microbiological testing techniques, environmental monitoring techniques and scientific knowledge. Conducting effective training and coaching of analysts. Knowledge of laboratory safety practices. Understanding of relevant scientific and technical principles. Written and verbal communication skills. Attention to detail. Willingness to learn and share knowledge. Communicates effectively with peers, management and cross-functionally across the site. Critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments. Time management and organizational skills. Ability to mentor peers on day-to-day tasks and more technical tasks; cooperative and works well with a team. Duties and Responsibilities General: Communication: Provides exceptional communication and inputs to Tier and Escalation boards, as required. Updates Tier Boards and Leads Shift Tier meetings. Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required. Communicate effectively with management regarding task completion, roadblocks and needs. Fill in for Supervisor as shift point-of-contact when required Demonstrates proper aseptic technique when performing microbiological testing or environmental monitoring. Approves documentation as required by for all laboratory testing and environmental monitoring procedures Participate in more complex projects and continuous improvement efforts. Provide SME input to other teams/projects/investigations. Performs assigned tasks to support document revision, projects, CAPAs and investigation/deviation tasks. Prepares weekly testing schedules for department. Interacts with departments outside of QC (Manufacturing, Manufacturing Science & Technologies, Quality Assurance, and Maintenance). Technical QC Microbiology Skills/Assignments: Prepares schedules, sample labels via LIMS and/or worksheets as needed. Performs environmental monitoring, including utilities monitoring/testing, of manufacturing suites as needed. Participates/supports Aseptic Processing Simulations, media unit inspection and restoration activities as needed. Maintain Aseptic Area qualification status. Perform sample receipt and processing as needed. Routinely performs tests such as (but not limited to) bacterial endotoxin testing, sterility testing, Growth Promotion, and incoming media/reagent QC as needed. Performs Gram Stain analysis, subculturing, and microbial identification of microorganisms and any associated follow up actions as needed. Execute protocols, methods, and procedures with adherence to cGMP documentation requirements. Perform testing/monitoring activities associated with protocols or special projects as required. Performs Laboratory Maintenance: Utilizes tracking tools and follows applicable procedures to complete routine equipment/instrument maintenance and housekeeping. Ordering supplies via purchase requests, move orders, and coordination through Inventory Management. Performs inventory and receipt of Materials and stocking lab supplies. Oversees the Execution and Planning of departmental training: Complete necessary training to become a qualified trainer. Effectively train new analysts to general job duties and specific testing and monitoring activities. Document training per procedural and cGMP requirements. Coordinate and execute training plan in coordination with management. Coach other analysts in troubleshooting microbiology methods, EM techniques and scientific equipment. Act as a mentor for other analysts, freely sharing knowledge and experience. Assists with developing best practices in the laboratory. Controlled Documents/Documentation: Performs management of worksheets/logbooks requests, life cycle, and reconciliation as assigned. Draft and review technical documents, such as SOPs and protocols; serves as technical reviewer of appropriate departmental procedures Work Order Management for logbook review, LIMS sample aging, and sampling uploads. Responsibility for the coordination and on-time completion of assigned batch release tasks. Performs peer review per applicable controlled documents: Completes test and sample authorization in LIMS; Paperwork review/approval; review of outside testing results. Review all data in accordance with applicable procedures and cGMP requirements. Apply technical knowledge and abilities to ensure all testing is performed in a compliant matter. Complete all review in accordance with required timelines. Assists with peer review, verification, and approval of data, as required. Own and on-time completion of action items assigned in QMS. Provides technical support to Technical Operations team for asset induction. Assists in the drafting and routing of special studies and test plan generation/execution. Participates in routine compendial review. Participates in Method Validation. Assists with the generation of trending reports. Assists with impact assessments associated with change controls. Working Conditions • The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 8 hours, approximately 5 times per week. • May require aseptic gowning into sterile environment. • The incumbent may be working around hazardous materials to include chemical agents at least 8 hours per day. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. BMSBL
LI-Onsite If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.