Document Control Specialist at Bristol-Myers Squibb

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, RadiopharmaceuticalsIndustries

Requirements

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
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

Responsibilities

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

Skills

Document Control

Quality Assurance

GMP

Document Management System

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

Land your dream remote job 3x faster with AI

Try Jobo Free