In- Process Quality Assurance Technician

Granules Pharmaceuticals Inc.; Chantilly (VA); On-site; USD 45,000 - 65,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, VA, seeks a QA Technician to support cGMP compliance on the manufacturing floor. You will perform line clearance, water sampling, environmental monitoring, and in-process QA testing.

Responsibilities include record review, equipment swab collection, batch documentation, training records, and initiating change controls. Minimum 1–2 years in pharma/food, HS or associate degree, strong attention to detail.

Qualifications

• Background in cGMP compliance within pharmaceutical manufacturing.
• Experience maintaining cGMP documentation.
• Ability to manage multiple priorities with attention to detail.

Responsibilities

• Perform line clearance, material verification.
• Collect purified water samples for testing; trend results.
• Coordinate environmental monitoring in GMP areas.
• Log books and batch review.
• Check equipment cleanliness; collect swabs; release equipment to operations.
• In-process QA testing; archival of SOPs and batch docs.
• Review in-process SOPs and identify gaps; initiate changes.
• Maintain employee training records; perform other supervisor-assigned tasks.

Skills

cGMP compliance

Documentation

Quality monitoring

Education

High School or Associate degree

Job description

Description

Granules Pharmaceuticals Inc., (GPI) has worked towards strengthening our core for the past 40 years and is currently the 4th largest generic pharma company in the US for controlled substances!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

The QA Technician compliance with cGMP and SOP’s and systems. This position is responsible for daily floor monitoring., water sampling for testing, swab collection. In-process testing, line clearance. Monitor manufacturing personnel follow and adhere to SOP pertaining to Manufacturing floor activities.

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 SOP’s, Batch documentation.
• Review the In-process SOP’s 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

We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.