QA Associate

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, orschedule 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 thestatus 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 FDAguidelines, GXPs regulations and internal SOPs

-Participates in Quality programs, procedures and controls to ensure that products conform toestablished 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 FDAguidelines and MHRA guidelines

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