Eric H. Email & Phone Number

Cambridge, Massachusetts, United States

• Conduct daily walkthroughs of Manufacturing areas to monitor, processes, and controls, ensuring that performance and quality of products conform to established standards and agency guidelines.
• Assist with continuous improvement by providing quality feedback on GxP and documentation behaviors to our cross-functional partners.
• You will prioritize accurate, and complete execution of GMP documentation review to support product disposition.
• Support our cross-functional teams (i.e., MFG, FAC, ENG..) to help resolve routine or non-routine compliance concerns as well support Manufacturing processes that requires QA presence on the floor. Support other tasks.
• Perform reconciliation and archiving of GMP documentation according to procedures.
• Perform Quality transactions within the SAP ERP, LIMs, and Trackwise Systems.Maintain compliance with all required training on department specific procedures.

Lexington, Massachusetts, United States

Ensures all testing required to maintain a compliant facilities and critical utilities is executed as required, including laboratory testing for endotoxin, bioburden, environmental monitoring, etc. They ensure all testing processes, monitoring and departmental documentation meet required standards.

Lexington, Massachusetts, United States

• Primary duty for this position is operational support for the Manufacturing and QC GMP functions, both for cross-functional teams as well as for core laboratory operations support. Roles will focus on support.
• Discretion/Latitude:General supervision and instructions given for routine work and detailed instructions given for new activities or special assignments
• Impact:Errors may be detected and corrected but may cause moderate loss of time or customer/user dissatisfaction.

Lexington, MA

Lexington, Massachusetts

Associate’S Degree, Biotechnology& Compliance

High School

Activities and Societies: AFJROTC, Volleyball, Encampment: practicing leadership skillsjoined the AFJROTC Program during freshmen year of.