Senior Specialist, Quality Assurance Investigations, Cell Therapy

Bristol Myers Squibb•Devens, MA

8d•Onsite

About The Position

The Senior Specialist, Quality Assurance Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines.

Requirements

Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheet, etc. and ability to learn and work with new software applications.
Ability to interpret data & results, understand problems with few variables and critically assess and provide feedback on proposed CAPA.
Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
Ability to work in a fast-paced team environment and changing priorities.
Detail oriented and task focused with ability to meet deadlines and support work prioritization.
Able to work across functional groups and teams to ensure requirements are met.
Self-motivated and contribute to a positive team environment.
Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
Curious and ability to think critically to create innovative solutions.
Bachelor's degree in STEM field preferred. High school diploma/ Associate's degree with equivalent combination of education and work experience may be considered.
4+ years of experience in a regulated industry with 1+ year deviation experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Demonstrated experience with electronic system and databases
Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

Responsibilities

Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
May author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
Ensure the corrective/ preventive actions are robust and adequately address the root cause.
May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
Support internal and external inspections as required.
Maintain compliance with assigned learning plan.
Support development and delivery of training content to cross functional teams.
Lead meetings and represent function at cross functional meetings.
Share data/ knowledge within and across team.
Build & maintain strong relationships with partner functions.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
unlimited paid sick time
up to 2 paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
an annual Global Shutdown between Christmas and New Years Day.