Senior Specialist, Quality Assurance Investigations, Cell Therapy Devens - MA - US R1602076 Pos

Position: Senior Specialist, Quality Assurance Investigations, Cell Therapy Devens - MA - US R1602076 Pos[...]
## Senior Specialist, Quality Assurance Investigations, Cell Therapy Devens - MA - USFind out how well you match with this job
** 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:  
** Position:
** Senior Specialist, Quality Assurance Investigations, Cell Therapy#
** Location**:
Devens, MA
** 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:
** Position Summary
** 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.
** Key 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.
** Qualifications & Experience
**** Specific Knowledge, Skills, Abilities:
*** 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…