In- Process Quality Assurance Technician
Granules Pharmaceuticals
Summary
The QA Technician ensures compliance with cGMP and SOPs and systems. This position is responsible for daily floor monitoring, water sampling for testing, swab collection, in-process testing, and line clearance. Monitor manufacturing personnel to ensure they follow and adhere to SOPs pertaining to manufacturing floor activities.
Job description
Job Description/Responsibilities:
- Perform line clearance, material verification
- Collect purified water sample for testing, trending the results
- Co-ordinate Environmental monitoring in GMP area
- Log book and Batch record review
- Check the equipment cleanliness and Equipment Swab collection, Equipment release to the operations
- In process QA testing
- Archival of SOPs, Batch documentation
- Review the In-process SOPs and identify the gaps
- Initiation of Change control/Incidents
- Maintain the employee training records
- Perform any other activity as assigned by the Supervisor
Requirements
- A background in cGMP compliance within the pharmaceutical manufacturing industry is required
- Experience in maintaining cGMP documentation
- Ability to manage multiple priorities and re-prioritize tasks, as required
- Flexible and able to adapt to company growth and evolving responsibilities
- Strong attention to detail and excellent organization
Minimum Education/Experience:
- High School diploma, or Associate degree
- At least 1 to 2 years' experience in pharmaceutical/food industry
Requirements
- Background in cGMP compliance within the pharmaceutical manufacturing industry
- Experience in maintaining cGMP documentation
- Ability to manage multiple priorities and re-prioritize tasks
- Flexible and able to adapt to company growth and evolving responsibilities
- Strong attention to detail and excellent organization
- High School diploma or Associate degree
- At least 1 to 2 years' experience in pharmaceutical/food industry
Company overview
Granules Pharmaceuticals Inc. (GPI) is a 100% US-based subsidiary of Granules India Limited, operating as a vertically integrated pharmaceutical manufacturing company headquartered in Chantilly, Virginia. The company specializes in complex, low-volume oral solid dosage forms including tablets, capsules, powders, and oral solutions developed and produced in compliance with TAA standards. With a US FDA and DEA-approved facility spanning over 100,000 square feet, GPI focuses on delivering high-quality, affordable pharmaceutical solutions to the healthcare market. The company has established R&D and manufacturing capabilities for immediate release tablets, multi-particulate pellets, modified release dosage forms, and other specialized pharmaceutical products. As of recent reports, GPI has filed 34 ANDAs with 31 approved and 3 under review, and has commercialized 43 products including 17 filed by Granules India Limited. The company also operates Granules Consumer Health (GCH), a wholly owned LLC focused on private label OTC products in the US market.