QA Document Control Sr. Specialist - Bristol Myers Squibb

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) Sr Specialist supports the GXP Document Control operations for the BMS Bothell site, including the document change control process, issuance and reconciliation of controlled forms and logbooks and management of archival and retention of GXP Records, leads projects to support QADC programs, and owns Quality Records on behalf of QADC when required.

Duties/Responsibilities

Responsibilities:

• 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. 

Reporting Relationship

• This role reports to the Senior Manager II, of QA Document Control.

Qualifications

Competencies:

• 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. 

Education & Related Work Experience Requirements:

• Bachelor's degree in STEM field preferred. High school diploma/ associate degree with equivalent combination of education and work experience may be considered.
• 4+ years of relevant / transferable cGMP experience preferred
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred
• Project management experience preferred
• Experience with EDMS is required.
• Demonstrated experience with quality management systems.
• Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g., TrackWise, Veeva, SAP, LIMS, Documentum)

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.
• 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.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

The starting compensation for this job is a range from $82,000 - $102,000, 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 isperformed. Final, individual compensation is decidedbased ondemonstratedexperience.

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.

Benefit offerings aresubject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

BMSCART

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 toadastaffingsupport@bms.com. Visitcareers.bms.com/eeo-accessibilityto 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.