QA Associate (2nd Shift) - Pharmaceutical Manufacturing

Job description

Description: **This is an On-Site Position** Job Summary: The QA associate for documentation ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines. JOB DUTIES & RESPONSIBILITIES: - Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements. - Manage the routing, review, approval, distribution and archival of new and revised controlled documents. - Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports. - Archive and maintain hardcopy and electronic copies of batch records files, audit files, vendor files, product, label files and change history files. - Control and issuance of labeling components. - Manage all document control logbooks and spreadsheets. - Perform the r...