Documentation Specialist

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

Major Duties and Responsibilities

• Works with Field Quality and Manufacturing group to deliver timely batch record review across all shifts (both upstream and downstream manufacturing).

• Develops appropriate disposition metrics, works with manufacturing personnel to achieve said targets. Generates and reports on metrics on agreed frequency.

• Works with manufacturing group and Field Quality groups to drive towards real-time review of batch records.

• Drives continuous improvements for right first-time batch records, minimizing/eliminating comments. Drives comment consistency.

• Creates training materials for subject matter expect input.

• Responsible for document related corrective and preventive actions.

• Revises standard operating procedures.

• Track and manage periodic review of approved manufacturing procedures.

• Provide support to lead investigator re manufacturing investigations.

• Have well-developed knowledge of company procedures and policies and of information sources.

• Frequently interacts with area management, outside customers and functional peer groups across various departments.

Knowledge and Skill

• Associates Degree in science, engineering, biochemistry or related discipline is preferred or equivalent professional experience required

• 6-8 years of experience in highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations

• Must possess excellent communication skills as well as proven written and verbal skills

• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment

• High proficiency required in Microsoft Office applications especially Word, Excel and PowerPoint

• Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives

• Position requires flexibility to quickly adapt to changing work environment and schedules. Weekend, holiday and overtime may be required

• Proficiency with Syncade and DeltaV a must

• Experience with Trackwise, Maximo, and SAP required

• Familiarity of all unit operations is preferred Media, Buffer formulations, chromatography, TFF, BRX, cell separation, etc...)

#LI-Hybrid

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.