Sr Specialist, Quality Assurance Records Management

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. 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.

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for BMS Jump site records management. Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.

Key Responsibilities:

• 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
• Thorough Knowledge of Records Management, Scanning and organization functions
• 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
• 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.
• Assist with Insurance and Reconciliation of Controlled Forms and Logbooks
• Take on process improvement projects

Competencies:

• Strong communication and customer service skills.
• Experience with Part 11 adherence regarding scanning of records and electronic archiving.
• 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
• Strong knowledge of cGMPs and domestic regulatory requirements
• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing 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., Content Manager Records Software)

Education & Related Work Experience Requirements:

• Bachelor’s degree or equivalent. Library Science a plus. High school diploma/ associate’s degree with equivalent combination of education and work experience may be considered.
• Minimum of 3+ years of relevant document control records management experience in a cGMP/FDA regulated environment

BMS CART

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.

Compensation Overview:

Bothell - WA - US: $83,100 - $100,703

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided b