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.
· 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 release of finished product batches packaged.
· Provide new hire training on GMP’s, Safety, and Pharmacovigilance and maintain the training program documentation.
· Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.
· Collaborate with team members to ensure timely deliverables for documentation.
· Ensuring all documents are up to date with respect to version control and issuance
· Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints.
. cGMP Compliance in Document Control.
. Any other activity as assigned by the Supervisor
Knowledge & Skills
Experience & Education
Physical Requirements/Working Environment
The job skills required for QA Associate include Quality Assurance, QA, Packaging, Written Communication, Change control,and Chemistry etc. Having related job skills and expertise will give you an advantage when applying to be a QA Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Associate. Select any job title you are interested in and start to search job requirements.