IN-Process Quality Assurance Technician(2nd & 3rd Shift)

Granules•Chantilly, VA

10h

About The Position

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 verifications 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
High School diploma, or Associate degree.
At least 1 to 2 years’ experience in pharmaceutical/food industry.
Quality assurance within Pharmaceutical Industry: 2 years highly preferred
Manufacturing: 2 years (Preferred)
Document management: 2 years (Preferred)
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.
Multiple priorities and re-prioritize tasks.
At least 2 -3 years of experience in a quality assurance role in a cGMP-regulated environment.
A college Degree preferably in sciences (i.e., Biology, Chemistry etc.), or related discipline

Responsibilities

Perform line clearance, material verifications
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.