Job Type
Full-time
Description
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.
Minimum 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 responsibilitiesStrong attention to detail and excellent organizationMinimum Education / Experience
High School diploma, or Associate degree.At least 1 to 2 years' experience in pharmaceutical / food industry.Benefits :
401(k)401(k) matchingDental insuranceDisability insuranceEmployee assistance programHealth insuranceHealth savings accountLife insurancePaid time offReferral programVision insuranceRequirements
Required Qualifications :
Quality assurance within Pharmaceutical Industry : 2 years highly preferredManufacturing : 2 years (Preferred)Document management : 2 years (Preferred)Knowledge & Skills
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.Experience & Education
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