Bristol Myers Squibb
Apply to the
Document Control Specialist
role at
Bristol Myers Squibb .
We are seeking a proactive professional to manage the document control system for a new Radiopharmaceutical facility in Indianapolis, IN.
Working with Us Challenging. Meaningful. Life‑changing. Working at Bristol Myers Squibb transforms patient lives and offers growth opportunities with high‑achieving teams.
Summary The Document Control Specialist is responsible for tactical oversight and maintenance of the document control system, acting as the primary contact for document control support and ensuring quality programs align with clinical development and GMP commercial operations.
Responsibilities
Manage creation, review, approval, and issuance of GxP controlled site documents and records (batch records, logbooks, forms, procedures, protocols, templates, and reports).
Oversee the EDMS document lifecycle workflows, assignment of reviewers/approvers, and training tasks.
Review document format and metadata to ensure compliance with approved templates, procedures, and EDMS requirements.
Provide guidance to document initiators, owners, and users to ensure regulatory compliance and assist with EDMS workflow issues.
Maintain periodic review of controlled documents and partner with owners for timely reviews.
Coordinate with other departments to enforce uniform quality standards for the site.
Ensure compliance with the training program and update 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 or 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/state regulatory bodies.
Skills and Qualifications
Highly motivated, organized, and capable of independent work.
Working knowledge of 21 CFR Parts 11, 210, and 211.
Strong interpersonal and communication skills.
Professional ethics, integrity, and ability to maintain confidential information.
Physical Demands The role requires sitting, reaching, and speaking or hearing regularly; occasional lifting of up to 30 pounds. The job is performed in a laboratory environment requiring protective clothing, gloves, safety glasses, and handling of radioactive materials.
Work Environment The noise level is usually moderate.
Compensation Overview Indianapolis – RayzeBio – IN: $34.05–$41.26 per hour (full‑time).
Benefits Benefit offerings include medical, pharmacy, dental, vision care, wellbeing support, 401(k), disability and life insurance, paid holidays, vacation, flexible hours, and more. For full details, visit https://careers.bms.com/life-at-bms.
Equal Employment Opportunity BMS is committed to inclusivity and provides reasonable workplace accommodations. Contact adastaffingsupport@bms.com for assistance. For full EEO statement, visit careers.bms.com/eeo-accessibility.
COVID‑19 Vaccination BMS recommends employees be fully vaccinated for COVID‑19 and keep boosters up to date.
Additional Information Details on occupancy structure, remote work options, and clarification for residents of Los Angeles County are available on our website.
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Document Control Specialist
role at
Bristol Myers Squibb .
We are seeking a proactive professional to manage the document control system for a new Radiopharmaceutical facility in Indianapolis, IN.
Working with Us Challenging. Meaningful. Life‑changing. Working at Bristol Myers Squibb transforms patient lives and offers growth opportunities with high‑achieving teams.
Summary The Document Control Specialist is responsible for tactical oversight and maintenance of the document control system, acting as the primary contact for document control support and ensuring quality programs align with clinical development and GMP commercial operations.
Responsibilities
Manage creation, review, approval, and issuance of GxP controlled site documents and records (batch records, logbooks, forms, procedures, protocols, templates, and reports).
Oversee the EDMS document lifecycle workflows, assignment of reviewers/approvers, and training tasks.
Review document format and metadata to ensure compliance with approved templates, procedures, and EDMS requirements.
Provide guidance to document initiators, owners, and users to ensure regulatory compliance and assist with EDMS workflow issues.
Maintain periodic review of controlled documents and partner with owners for timely reviews.
Coordinate with other departments to enforce uniform quality standards for the site.
Ensure compliance with the training program and update 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 or 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/state regulatory bodies.
Skills and Qualifications
Highly motivated, organized, and capable of independent work.
Working knowledge of 21 CFR Parts 11, 210, and 211.
Strong interpersonal and communication skills.
Professional ethics, integrity, and ability to maintain confidential information.
Physical Demands The role requires sitting, reaching, and speaking or hearing regularly; occasional lifting of up to 30 pounds. The job is performed in a laboratory environment requiring protective clothing, gloves, safety glasses, and handling of radioactive materials.
Work Environment The noise level is usually moderate.
Compensation Overview Indianapolis – RayzeBio – IN: $34.05–$41.26 per hour (full‑time).
Benefits Benefit offerings include medical, pharmacy, dental, vision care, wellbeing support, 401(k), disability and life insurance, paid holidays, vacation, flexible hours, and more. For full details, visit https://careers.bms.com/life-at-bms.
Equal Employment Opportunity BMS is committed to inclusivity and provides reasonable workplace accommodations. Contact adastaffingsupport@bms.com for assistance. For full EEO statement, visit careers.bms.com/eeo-accessibility.
COVID‑19 Vaccination BMS recommends employees be fully vaccinated for COVID‑19 and keep boosters up to date.
Additional Information Details on occupancy structure, remote work options, and clarification for residents of Los Angeles County are available on our website.
#J-18808-Ljbffr