Senior Specialist, Field Quality

Role Summary

Senior Specialist, Field Quality – Devens, MA. Provides QA floor support for complex manufacturing activities, conducts batch record reviews to support product release, and performs GMP area walkthroughs. Trains team members on routine facility quality tasks and supports inspection readiness. Ensures electronic and paper documentation requiring QA review complies with corporate and site procedures, cGMP regulations, and other guidelines. May review quality master data, author or revise QA SOPs, and support Master Batch Records approvals and product release activities.

Responsibilities

• 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 requiring 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 QA specific SOPs and may provide QA 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

Qualifications

• A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on quality

Education

• B.S. in science, engineering, biochemistry or related discipline, or its equivalent

Skills

• 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