QA Associate, Quality Compliance; Generic Pharma

QA Associate, Quality Compliance (Generic Pharma)

Company Overview: Granules Consumer Health LLC is a subsidiary of Granules India LTD, a vertically integrated pharmaceutical company based in Hyderabad, India, with offices in Manassa, Virginia. The company serves as Granules’ front-end division for private label over-the-counter (OTC) products in the US. With 106 employees and annual revenue of $76.64 million, it focuses on manufacturing, regulatory compliance, and customer service.

• Responsible for incoming inspection of bulk, packaging components, packaged finished product and outgoing product.
• Perform In-process Quality Assurance job functions and support to the packaging operations.
• Track controlled documents through issuance of document control numbers, logbooks, change requests, and document status reports.
• Responsible for periodic review of logbooks issued at the facility.
• Archive and maintain hardcopy and electronic copies of batch records files, audit files, label files and change history files.
• Manage all document control logbooks and spreadsheets.
• Assist in scanning of documents as needed.
• 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.
• Perform floor audits for facility as per the SOP requirements.
• Collaborate with team members to ensure timely deliverables for documentation.
• Ensure 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.
• Maintain cGMP compliance of the facility.
• Carry out any other activity as assigned by the supervisor.

• Bachelor's degree.
• At least 2 years of QA experience in pharmaceutical or related industry.
• Experience working with Quality Management Systems.

Entry level

Full-time

Quality Assurance

Software Development