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.
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, Smartsheets 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.
Minimum Requirements:
Bachelor's degree in STEM field preferred. High school diploma/ Associates 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.
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:
Devens - MA - US: $89,780 - $108,789
Eligibility for specific benefits listed on o
Benefits
Equity / stock options
Additional Information
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 Senior Specialist, QA 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.
Bristol-myers Squibb · Devens, MA