Opportunity Description
Quality Assurance Specialist II
Location: Bedford, MA
Schedule: Monday - Friday 8am - 4pm
Industry: Biotechnology / Medical Device
About the Role
We are seeking a Quality Assurance Specialist to support quality and compliance activities within a regulated manufacturing environment. This individual will play a key role in ensuring products and processes meet cGMP, FDA, and ISO 13485 requirements while maintaining the integrity of the Quality Management System (QMS).
The ideal candidate will have experience in quality assurance, batch record review, investigations, and compliance within the life sciences, biotechnology, pharmaceutical, or medical device industry.
Responsibilities
+ Support and maintain compliance with cGMP, FDA, and ISO 13485 quality requirements.
+ Review, approve, and release batch production records and raw materials.
+ Lead and support deviation investigations, root cause analysis, and corrective actions.
+ En...
Location: Bedford, MA
Schedule: Monday - Friday 8am - 4pm
Industry: Biotechnology / Medical Device
About the Role
We are seeking a Quality Assurance Specialist to support quality and compliance activities within a regulated manufacturing environment. This individual will play a key role in ensuring products and processes meet cGMP, FDA, and ISO 13485 requirements while maintaining the integrity of the Quality Management System (QMS).
The ideal candidate will have experience in quality assurance, batch record review, investigations, and compliance within the life sciences, biotechnology, pharmaceutical, or medical device industry.
Responsibilities
+ Support and maintain compliance with cGMP, FDA, and ISO 13485 quality requirements.
+ Review, approve, and release batch production records and raw materials.
+ Lead and support deviation investigations, root cause analysis, and corrective actions.
+ En...
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