Summary: Responsible for assuring conformance to product specifications, Good Manufacturing Practices, and the Quality Management System, also acts as the contact person for day-to-day quality department activities.

Quality Assurance Specialist I

May be responsible for scanning and filing of batch records, equipment files, validation protocols, etc.

Responsible for setting up and maintaining training files and completing initial training for new employees.

Responsible for batch record review, preparing certificate of analysis for shipments, coordinate the shipment of final products with Manufacturing and Materials.

Assists in the updating, review and maintenance of all quality documentation such as SOP's, validation protocols and other documents to ensure compliance with company policy, and all applicable regulatory requirements.

Assists or performs ongoing GMP training.

May act as the Quality representative for the daily shipping meeting.

May act as the point person regarding daily activities and priorities in Quality Assurance.

May perform audits of the laboratory.

Ensures timely closure of all non-conformances in accordance with the established guidelines and database systems.

Performs tasks requiring additional experience.

May train new personnel.

Perform other duties or special projects as assigned

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.