Title: QA Associate I Location: 118 7330 Carroll Rd San Diego CA 92121 Duration: 3 months Schedule M-F 8:30 to 4:30p on site Education: Associate’s degree or equivalent knowledge and experience. Requirements:
Six Sigma or ASQ certification preferred.
Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form
Must be able to use existing procedures to solve routine and non-routine problems
Must be able to utilize all elements of the quality system to identify, classify and control the status of incoming materials
Responsibilities:
Responsible for inspection of incoming materials for GMP production
Assist with packaging floor activities for primary and secondary (equipment/room approval,
facility compliance, auditing, label inspection, line clearance, etc.)
Reviews production batch records, logbooks and other associated documents
Performs Quality verification of just-in-time labeling activities
Performs document issuance, scanning, filing and archival activities
Revises SOPs, Work Instructions and Forms pertaining to their area of focus, as needed
Assists in the execution of efficiency improvement projects with guidance
Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs
-Participates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelines
Ensures gathering of data, investigations and deviations are timely and compliant
Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.