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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. 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.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.<ul><li>RayzeBio is seeking a Quality Control Environment Monitoring Supervisor, reporting to the Director- Microbiology Quality Control.&nbsp; The position will provide oversight for the environmental monitoring program supporting the GMP manufacturing operations related to radiopharmaceuticals. This role will be responsible for the day-to-day EM activities including viable/non-viable monitoring. The supervisor will ensure data trending are executed in compliance with regulations, and company quality standards, troubleshooting efforts, ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radioisotopes and radiopharmaceutical product release.&nbsp; The Environment Monitoring Supervisor will collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. The position will require the applicant to work with and around ionizing radiation and hazardous chemicals.</li><li>The position will be located at RayzeBio’s manufacturing plant, in Indianapolis, IN.</li><li>Job Responsibilities</li><li>Manage EM program<ul><li>Supervise EM technicians /analysts performing viable, non-viable, personnel, settling plates monitoring in ISO- classified and controlled spaces.</li><li>Schedule routine and non-routine EM activities to support manufacturing operations and facility readiness.</li><li>Oversee execution of environmental and utility sampling including microbial identification workflows.</li><li>Ensure laboratory activities follow SOPs, aseptic techniques, gowning procedures and safety requirements.</li><li>Review and/or approve EM data, escalate excursions.</li><li>Lead or support investigations for EM -related investigations, including root cause analysis and CAPA development to ensure timely close-out.</li><li>Ensure EM program documentation such as SOPs, forms, maps are current and audit-ready.</li><li>&nbsp;Ensure EM trending, monthly/quarterly reports are performed in a timely manner.</li><li>Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, validation/verifications and equipment qualifications.</li><li>Develop and maintain appropriate documentation, particularly data analysis and team KPI’s.</li></ul></li><li>Team Management<ul><li>Supervise a team of EM technicians /analysts.</li><li>Assign tasks and prioritize workload to ensure timely completion of in an “on-time” and “right first time” manner.</li><li>Foster a positive and collaborative work environment within the lab and with external stakeholders both within the site and outside the site.</li><li>Coach team members, conduct performance evaluations and support career development.</li></ul></li><li>Continuous Improvement<ul><li>Support continuous improvement programs for EM such as new EM technologies and improve data visibility.</li><li>Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratories.</li></ul></li><li>Release of isotope, product and other studies<ul><li>Collaborate with Manager and/or Reviewer to ensure all documentation for release is reviewed.</li><li>Work with Manager and/or Investigation Writer to ensure any discrepancies are resolved in a timely manner.</li></ul></li><li>Quality Assurance/Regulatory Compliance<ul><li>Assist in the routine calibration and maintenance of laboratory equipment.&nbsp; Ensure schedule compliance to ensure GMP readiness.</li><li>Work with Quality Assurance and Management to implement internal audits.</li><li>Participate in troubleshooting of issues and implement corrective actions to improve quality processes as a result of investigations or internal audits.</li></ul></li><li>Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, and other regulatory agencies as needed).</li><li>Weekend work, early starts, or late ending times may be required.</li><li>Up to 10% of travel may be required.</li></ul><ul><li>Education and Experience</li><li>·BS in microbiology or related field with 5+ years of direct radiopharmaceutical experience or 5+ years of experience in pharmaceutical field, OR MS in microbiology or related field with 5+ years of experience in pharmaceutical field.</li><li>·At least a year of supervisory experience. &nbsp;</li><li>·A strong background in microbiology and aseptic manufacturing is required.</li><li>Preferred Experience:</li><li>·Experience in radiopharmaceutical field</li><li>·Experience handling radioactive materials</li></ul><ul><li>Skills: </li><li>Highly motivated and organized professional with the ability to work independently or in a team environment.</li><li>Proficient in viable and non-viable monitoring techniques</li><li>Strong understanding of cleanroom classifications</li><li>Attention to details and data integrity</li><li>Experience with software such as Sherpa or LIMs or equivalent data systems</li><li>Multi-disciplined scientist with GMP experience. Radiochemistry experience preferred.</li><li>Experience with root cause techniques such as 6 M’s, 5 Why’s, fishbone, or similar preferred.</li><li>Very personable with strong communication skills and cross-functional collaboration</li><li>Ability to multi-task and prioritize work based on multiple workflows.</li><li>Good organizational skills are required.</li><li>Work with multiple computer systems, including Microsoft Office.</li><li>Excellent professional ethics, integrity, and ability to maintain confidential information</li></ul><ul><li>Physical Demands</li><li>While performing the duties of this&nbsp;job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this&nbsp;job&nbsp;include&nbsp;close vision and distance vision.&nbsp;</li><li>This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.</li><li>Work&nbsp;Environment</li><li>The noise level in the&nbsp;work&nbsp;environment is usually moderate.</li><li>#LI-ONSITE</li></ul>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.Compensation Overview:Indianapolis - RayzeBio - IN: $107,904 - $130,754&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:<ul><li>Health Coverage: Medical, pharmacy, dental, and vision care.</li><li>Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).</li><li>Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.</li></ul>​Work-life benefits include:Paid Time Off<ul><li>US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)</li><li>Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays</li></ul>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.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 a supportive culture, promoting global participation 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 ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.Supporting People with DisabilitiesBMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Candidate RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Data ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at <a href="https://careers.bms.com/fraud-protection" target="_blank">https://careers.bms.com/fraud-protection</a>.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at <a href="mailto:TAEnablement@bms.com" target="_blank">TAEnablement@bms.com</a>. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1597921 : Quality Control Environment Monitoring Supervisor

Bristol Myers Squibb

Quality Control Environment Monitoring Supervisor

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. 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.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.SummaryThe Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN.&nbsp; The Senior QA Operations specialist will be providing oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures.&nbsp; The Senior QA Operations specialist will also be responsible for material and batch disposition activities.&nbsp; This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Material and Lot Disposition.&nbsp; This person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.&nbsp;Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.<ul><li>Build and maintain cross functional relationships to improve processes and resolve issues.</li><li>Provide quality oversight on manufacturing and validation activities.</li><li>Perform real time review of manufacturing records.</li><li>Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.</li><li>Provide guidance on the handling of quality and shop floor activities.</li><li>Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.&nbsp;&nbsp;</li><li>Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.</li><li>Identify and report discrepancies from required work practices or procedures to management.&nbsp;</li><li>Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.&nbsp;</li><li>Participate as requested in the response team for audits and inspections by health authorities.&nbsp;</li></ul>Education and Experience<ul><li>BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred</li><li>Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry or a related industry</li><li>Experience working in a GMP aseptic manufacturing environment preferred.</li><li>Experience working with FDA or other regulatory authorities is preferred.&nbsp;</li></ul>Skills and Qualifications<ul><li>Expertise in GMP, Quality, material and product disposition </li><li>Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles </li><li>Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management&nbsp; </li><li>Team player who can work independently to achieve objectives in a fast-paced environment </li><li>Excellent verbal and written communication skills.&nbsp; </li><li>Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.&nbsp;</li><li>Knowledge of US, EU and rest-of-world cGMP regulations and guidance.&nbsp;</li><li>Knowledge and proven experience in FDA, EMA, or other regulatory authority.&nbsp;</li><li>Well-practiced in exercising sound judgment in decision-making.&nbsp;</li><li>Demonstrated prioritization and organization skills.&nbsp;</li></ul>Physical DemandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.  This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.&nbsp; Work EnvironmentThe noise level in the work environment is usually moderate.&nbsp; &nbsp;This position may require work outside of normal working hours or on weekends.&nbsp; #LI-ONSITEIf 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.Compensation Overview:Indianapolis - RayzeBio - IN: $82,236 - $99,650&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.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 a supportive culture, promoting global participation 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 ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.Supporting People with DisabilitiesBMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Candidate RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Data ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at <a href="https://careers.bms.com/fraud-protection" target="_blank">https://careers.bms.com/fraud-protection</a>.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

2 Procurement / Operations Jobs in Indiana