Bristol Myers Squibb Quality Assurance Floor Support Lead, 3rd Shift in Devens, Massachusetts
Provide Quality assistance and oversight during manufacturing of in-process intermediates and drug substance, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.
Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data.
Contributes to driving innovation through continuous improvement of quality processes as well as supporting manufacturing continuous improvement initiatives.
May provide guidance to less experienced staff.
Supports the Quality review and closure of manufacturing investigations.
Other duties as assigned.
This position is a Night Shift (3rd Shift) position that requires working hours of 5:00 pm to 5:00 am EST.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance.
Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.