Manager Quality Assurance Disposition Support Devens, MA
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Job Location:
Devens, MA - USA
Monthly Salary:
$ 100480 - 121756
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Summary
The Manager Quality Assurance Disposition Support Devens Cell Therapy role is responsible for the support of the overall Devens Disposition organization inclusive of systems metrics Quality System Records and deployment of priority projects.
This individual will provide support to all functions reporting through the Quality Disposition organization including incoming materials QA and disposition systems drug product disposition and Material Review Board. This individual will provide oversight of projects with Disposition impact APQR data compilation Disposition metrics CAPAs owned by Disposition Deviations owned by Disposition Change Control Impact Assessments Change Controls owned by Disposition product and will perform routine Material Review Board support.
Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. This role will interface with multiple departments including Supply Chain Manufacturing Quality Control Quality Assurance Project Management Digital Plant and Site Manufacturing Sciences & Technology
Key Responsibilities
Support the overall Quality Disposition (QD) Organization by:
Owning and driving Quality System records
Performing product and change impact assessments
Support the systems and data requests needed
Maintain QD monitoring tools and metrics
May represent the QD program in audits and inspections
Performing routine Drug Product and Incoming Material disposition as required during peak and overflow periods
Maintain inspection plans and SAP infrastructure for disposition operations
Perform testing for eSystem changes as needed
Other tasks as required by Quality Disposition leadership
Support the Material Review Board (MRB) program by:
Monitoring quality events and impact assessments as needed for potentially non conforming lots
Sending Pre-MRB Notification to Mgt and MRB stakeholders along with scheduling MRB meetings and deliverables
Collaborating with SMEs to obtain inputs and investigative information for MRB decision-making
Attending MRB meetings and assisting in determination with MRB available treatment options for patients
Managing confidential MRB documentation appropriately
Additional Qualifications/Responsibilities
Qualifications/Experience
Bachelors degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
4-5 years of experience in a regulated industry with 1 year quality experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Demonstrated experience with electronic system and databases
Ability to research understand intepret 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 complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation
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 prioritize work
Ability to think strategically meet deadlines and prioritize work
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 medium level issues and able to recognize Quality issues and solve problems
Curious and ability to think critically to create innovative solutions
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.
Compensation Overview:
Devens - MA - US: $100480 - $121756
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
