Specialist, Quality Assurance Shop Floor, 6AM-6PM at BristolMyers Squibb
Devens, MA 01434, USA -
Full Time


Start Date

Immediate

Expiry Date

03 Dec, 25

Salary

83540.0

Posted On

04 Sep, 25

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Biopharmaceuticals, Decision Making, Quality Processes, Product Complaints, Technical Writing, Mes, Batch Records, Tableau, Smartsheet, Manufacturing, Change Control, Deviations, Sap, Facts, Cell Therapy

Industry

Pharmaceuticals

Description

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 .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.
The Specialist, QA Shop Floor Cell Therapy will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

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Responsibilities
  • Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
  • Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
  • Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
  • Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
  • Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
  • Provide quality oversight for pre-planned return to service plans.
  • Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
  • Identify and propose improvements to programs, procedures, and practices.
  • Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
  • Review and provide feedback on documents such as forms, logbooks, and procedures.
  • Maintain compliance with assigned learning plan. Provide integration support of newer team members.
  • Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
  • Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
  • Participate in quality and shift meetings.
  • Build and maintain relationships with core partner functions and seek collaborative solutions.
  • Share data/knowledge within team by acting as a champion for quality-culture
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