Field Quality – QA Operations Senior Specialist

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 2 years focused on quality preferred.
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 or paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.

Quality floor support of complex manufacturing activities
Performs 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.
Perform training on routine facility Quality tasks for new team members.
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.
May support review of quality master data.
Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
May provide guidance to less experienced staff.
Support the Quality approval of Master Batch Records or Syncade Recipes.
Supports the Quality review and closure of no impact manufacturing deviations.
May support release of incoming or manufactured products.
Routine QA Floor Support Activities, including alarm review, logbook review, etc.
Other duties as assigned.