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 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

Position Summary:

The Quality Assurance Document Control (QADC) Senior Technical Writer supports the cGMP Document Control operations for the BMS Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.

Knowledge, Skills and Abilities:

Education:

• Bachelor’s degree or equivalent

Experience:

• Minimum of 3 years of relevant document control management experience in a cGMP/FDA regulated environment.
• Strong communication and customer service skills.
• Advanced technical writing skill set with the ability to to critically review documents while effectively inputting and expressing Quality principles.
• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred
• Strong knowledge of cGMPs and domestic regulatory requirements
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
• Commitment to achieve results by applying hard work, planning and organization, knows how to get things done both through formal and informal networks
• Ability to manage multiple priorities simultaneously, have a strong drive, sense of urgency and orientated on results.

Licenses/Certifications:

N/A

Responsibilities:

Primary responsibilities include:

• Assist with issuing production batch records, labels, and other controlled documents to support manufacturing operations
• Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
• Assist with managing the Document Center Archive room
• Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
• Write and revise document control procedures including participating in the development and roll-out of document control tools.
• Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
• Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
• Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections.
• Perform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data.
• Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders.
• Lead Document Control Projects as needed for continuous improvement and site wide implementations.

The starting compensation for this job is a range from $75,000 – $95,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

#LI-Onsite #BMSCART #Veteran

TRAVEL REQUIREMENTS:

☒ Not Applicable

WORKING CONDITIONS (US Only):

• Normal office working conditions.

• Duties are largely cognitive, but the job may occasionally require minimal motor skills for activities such as moving objects, operating a computer and/or most other office equipment, keyboarding and/or word processing.

• Requires sitting for extended periods of time, standing, visual acumen, and manual dexterity.

• Regularly required to stand and walk, occasionally required to stoop, kneel, crouch, or crawl, climb or balance.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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.

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.