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About the Role
Job Title: Quality Assurance Associate
Job Description
This role involves providing support for QA issues within the manufacturing suite and mitigating gaps and risks associated with all quality and GMP processes. The position requires running investigations for deviations, change controls, CAPAs, and out-of-specifications, as well as reviewing and authoring SOPs.
Responsibilities
+ Provide on-the-floor support for QA issues within the manufacturing suite.
+ Mitigate gaps and risks in quality and GMP processes.
+ Conduct investigations for deviations, change controls, and CAPAs.
+ Review and author SOPs.
+ Ensure compliance with regulations such as cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH.
+ Other duties as assigned.
Essential Skills Needed
+ Proficiency in quality assurance and document control.
+ Experience in batch record review, CAPA, and deviation management.
+ Strong ...
Job Description
This role involves providing support for QA issues within the manufacturing suite and mitigating gaps and risks associated with all quality and GMP processes. The position requires running investigations for deviations, change controls, CAPAs, and out-of-specifications, as well as reviewing and authoring SOPs.
Responsibilities
+ Provide on-the-floor support for QA issues within the manufacturing suite.
+ Mitigate gaps and risks in quality and GMP processes.
+ Conduct investigations for deviations, change controls, and CAPAs.
+ Review and author SOPs.
+ Ensure compliance with regulations such as cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH.
+ Other duties as assigned.
Essential Skills Needed
+ Proficiency in quality assurance and document control.
+ Experience in batch record review, CAPA, and deviation management.
+ Strong ...
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