Specialist, Field Quality

Bristol Myers Squibb•Devens, MA

4d•$81,800 - $99,117

About The Position

Provide Quality assistance and oversight to operations for in-process intermediates, manufactured products, and other GMP processes as required. Review and approve documentation associated with in-process materials and manufactured products, and assist with identifying, generating, and reviewing investigation records arising during day-to-day operations. Ensure manufactured products comply with applicable regulations and guidelines.

Requirements

Working knowledge of common computer systems such as MS Word and Excel.
A combination of two years of relevant experience in a regulated environment, or a combination of co-op experience and regulated-environment experience, is preferred.

Nice To Haves

Knowledge of biotech bulk and finished-product manufacturing and analytical testing.
Familiarity with U.S. and EU cGMP regulations and guidance.
Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test-result generation, inventory management, investigations, equipment tracking, and maintenance.
A bachelor's degree in science, engineering, biochemistry, or a related discipline, or equivalent.

Responsibilities

Provide quality floor support for minor and routine manufacturing activities.
Review routine manufacturing batch production records for media, buffer, and cryo in support of product release, in accordance with specifications and SOPs.
Conduct walkthroughs of GMP areas and document observations and areas of concern.
Support return-to-service walkthroughs and manufacturing inspection-readiness walkthroughs as needed and in accordance with procedures.
Ensure electronic and paper documentation requiring QA review complies with corporate and site procedures, cGMP regulations, and other industry guidelines.
May support quality review of manufacturing deviations.
May support release of incoming or manufactured products.
Perform routine QA floor support activities, including alarm and logbook review.
Perform other duties as assigned.

Benefits

Wellbeing support.
Retirement and financial protection benefits.
Medical, dental, vision, life, and disability insurance offerings.
Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
11 paid company holidays annually.
Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
Potential eligibility for discretionary incentive cash and stock opportunities.