Sr Specialist, Quality Assurance Records Management

• 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:

• Bachelors degree or equivalent. Library Science a plus. High school diploma/ associates 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 doesnt 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.

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 employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject 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 Years 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.

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 a supportive culture promoting global participation 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 an 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 to . Visit to 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.