Senior Specialist, Field Quality QA Operations

Summary

This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs, and supporting timely return-to-service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production use. The role also works closely with Manufacturing Operations to investigate and resolve manufacturing issues as they arise. Additionally, this position contributes to authoring and revising quality SOPs, supporting the review and closure of no-impact manufacturing deviations, and conducting proactive area inspections and readiness reviews to uphold both internal quality standards and external regulatory requirements. This is a high-visibility, floor-based role that is integral to real-time quality assurance, batch release readiness, and audit preparedness.

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, which requires QA review, is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines

Knowledge & Skill

• 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
• Field Quality may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Digital Plant, Site Engineering and Manufacturing staff
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Coordinates with higher level leads and/or supervisor on decisions and applies appropriate notification to management as appropriate

Basic Requirements

• Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is preferred
• 4 years of Quality Assurance experience within the pharmaceutical or medical device industry
• Batch record review experience

Working Conditions

Work is largely performed in a modern manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals. Use of Personal Protective Equipment (PPE) will be required in some portions of the facility, including appropriate gowning for working in a clean room environment.