QA Associate

1w1 week ago

Granules India Limited

Manassas, US · Full-time · $55,000 – $75,000

About this role

The QA Associate ensures compliance with cGMP and internal policies, procedures, and specifications. This on-site position performs inspections, batch record review, and quality system functions per cGMP, company SOPs, state, federal, and local laws. Knowledge of FDA regulations and ICH guidelines is required.

Daily duties include managing document control and archival systems for hardcopy and electronic records. Handle routing, review, approval, distribution, and archival of controlled documents. Track documents via Document Control numbers, logbooks, change requests, and status reports.

Archive batch records, audit files, vendor files, product, label files, and change history. Control issuance of labeling components and manage all document control logbooks and spreadsheets. Perform release of finished product batches and support new hire training on GMPs, Safety, and Pharmacovigilance.

Collaborate with team members for timely documentation deliverables and ensure SOPs are reviewed for relevance and accuracy. Maintain and close documents like reports, protocols, exceptions/deviations, CAPAs, change controls, and complaints. Work in a confined area with light to moderate lifting up to 10-15 lbs.

Requirements

cGMP compliance within the pharmaceutical manufacturing industry
Writing and maintaining cGMP documentation
Analyze data/information and resolve complex issues
Verbal and written communication skills
Work and communicate with cross-functional teams
Handle multiple priorities and re-prioritize tasks
At least two (2) years’ experience in a quality assurance role in a cGMP-regulated environment
Ability to sit at a computer terminal for an extended period of time

Responsibilities

Manage and maintain company document control and archival systems (hardcopy and electronic)
Manage the routing, review, approval, distribution and archival of new and revised controlled documents
Track controlled documents through 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
Perform the release of finished product batches packaged
Provide new hire training on GMP’s, Safety, and Pharmacovigilance and maintain training program documentation
Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls and complaints