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Document Control Specialist
Document Control SpecialistBristol-Myers Squibb • Indianapolis, IN, United States
Document Control Specialist

Document Control Specialist

Bristol-Myers Squibb • Indianapolis, IN, United States
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  • [job_card.full_time]
  • [job_card.part_time]
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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.

Summary

The Document Control Specialist is responsible for the tactical oversight and maintenance of document control system for a new Radiopharmaceutical facility in Indianapolis, IN. The Document Control Specialist will be a primary contact point for document control support. This position will utilize quality assurance knowledge in maintaining the quality program to be ready for clinical development and GMP commercial operations. Additional responsibilities may include providing support for corporate activities.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, procedures, protocols, templates, and reports.

Manage electronic document management system (EDMS) document lifecycle workflows and assignment of reviewers / approvers and training tasks.

Review the format and metadata of new documents to ensure compliance with approved templates, procedures and EDMS requirements.

Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations and assist users with EDMS workflow related issues.

Manage the periodic review of controlled documents and partner with document owners to ensure periodic reviews are completed within the required timelines.

Coordinate and liaise with other departments to facilitate uniform quality standards for the site.

Ensure that compliance to the training program is maintained and updated as needed.

Process DCR packages and review for correctness and completeness; monitor and update in-process documents.

Create, assign, and archive QA controlled lab notebooks and logbooks.

Education and Experience

  • BS / MS in a Science related discipline preferred
  • 3-5 years of quality assurance experience
  • Pharmaceutical and GMP experience preferred.
  • Experience working with FDA or other federal and state regulatory bodies.

Skills and Qualification

  • Highly motivated and organized professional with the ability to work independently.
  • Working knowledge of 21 CFR Parts 11, 210, and 211
  • Very personable with strong communication skills
  • Excellent professional ethics, integrity, and ability to maintain confidential information.
  • Physical Demands

    While 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 a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials .

    Work Environment

    The noise level in the work environment is usually moderate.

    #RayzeBio, #LI-Onsite, GPS_2025

    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 : $34.05 - $41.26per hour

    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.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

    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 :

    Health Coverage : Medical, pharmacy, dental, and vision care.

    Wellbeing Support : Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

    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.

    Work-life benefits include :

    Paid Time Off

    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)

    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

    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 : T he 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 Protocol

    BMS 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 Disabilities

    BMS 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 adastaffingsupport@bms.com . Visit careers.bms.com / () eeo-accessibility to access our complete Equal Employment Opportunity statement.

    Candidate Rights

    BMS 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 :

    Data Protection

    We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at .

    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 TAEnablement@bms.com . 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.

    R1594470 : Document Control Specialist Company : Bristol-Myers Squibb

    Req Number : R1594470

    Updated : 2026-01-09 03 : 20 : 32.092 UTC

    Location : Indianapolis-IN

    Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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    Document Control Specialist • Indianapolis, IN, United States

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