Quality Assurance Specialist

Quality Assurance Specialist

Location: Casa Grande, AZ

Duration: 12 months

Description:

Performs data and document audits to ensure application integrity, accuracy, consistency and completeness.

Prepares and issues final audit reports summarizing findings and noting corrective action.

Main Purpose of Role:

Summarize the main purpose of the role.

Coordinate sampling requirements for finished products.

This includes shipping, documentation and communication of sample status, document management (archival), and management of sample inventory.

Main Responsibilities:

Manage finished product samples by ensuring all samples have been pulled.

Documentation of sample status and sample inventory.

Archival of all documents and adherence to GMP requirements.

Shipment of samples for commercial stability and finished product testing.

Management of sample inventory, including coordination and documentation of all inventory practices.

Safeguard the environment and facilitate a safe and healthy workplace culture

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Performs other related duties and responsibilities, on occasion, as assigned.

Education:

Education Level:

High School diploma/GED

Education Level:

An equivalent combination of education and work experience

Experience/Background:

Experience Details:

Previous experience with Good Manufacturing Practices, particularly with documentation.

Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

Effective, efficient communication skills.

Required knowledge of applicable regulations, quality systems, warehousing, and distribution practices and systems, relevant manufacturing operations, and good quality practices.

Quality assurance experience with demonstrated ability to assess the quality of a process and/or product and ability to elevate potential problems.

Ability to work independently with minimal supervision.

Call Notes:

The main purpose of this role is to coordinate sampling requirements for finished products.

This includes shipping, documentation and communication of sample status, document management (archival), and management of sample inventory.

Experience:

Entry level role no high level role. Can have 1 year in Quality, Warehouse background, manufacturing Technician or GMP.

Desire to have:

Document, office or inventory.

Skills:

Detail oriented, self starter and organization.