Location
Dedham, MA, United States
Posted
July 25, 2026
Job Description
Job Duties
+ Demonstrate general knowledge of standard manufacturing compliance, quality disposition, and quality system review.
+ Partner closely with peers for the disposition of Plasmid, Drug Substance, and Drug Product.
+ Participate in quality-focused teams across broad ecosystem of functions.
+ Author and review SOPs, policies, and batch production/testing records to ensure compliance with cGMP operations.
+ Oversee and review executed electronic and paper batch record documentation.
+ Review manufacturing deviations and enforce adherence to current good manufacturing practices, SOPs, and manufacturing documentation and operations including modeling clean room behaviors.
+ Establish and follow written procedures for the clear and accurate documentation of equipment operation, process instructions, and process data.
+ Responsible for training adherence
+ Adherence to data integrity ...
+ Demonstrate general knowledge of standard manufacturing compliance, quality disposition, and quality system review.
+ Partner closely with peers for the disposition of Plasmid, Drug Substance, and Drug Product.
+ Participate in quality-focused teams across broad ecosystem of functions.
+ Author and review SOPs, policies, and batch production/testing records to ensure compliance with cGMP operations.
+ Oversee and review executed electronic and paper batch record documentation.
+ Review manufacturing deviations and enforce adherence to current good manufacturing practices, SOPs, and manufacturing documentation and operations including modeling clean room behaviors.
+ Establish and follow written procedures for the clear and accurate documentation of equipment operation, process instructions, and process data.
+ Responsible for training adherence
+ Adherence to data integrity ...