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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 .

Job Title: Document Control Specialist

Location: Indianapolis

*This is an on-site position located in Rayzebio's Indianapolis, IN site.

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

• Specialist: 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.

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

BMS has a diverse 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.

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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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.

Company: Bristol-Myers Squibb

Req Number: R1580850

Updated: 2024-05-19 01:51:30.600 UTC

Location: Lawrence Township-NJ

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.