Quality Assurance Associate I

FFF Enterprises•Flower Mound, TX

1d•Onsite

About The Position

The Quality Assurance Associate I is responsible for ensuring compliance to all policies and procedures at the local distribution center in order to protect and maintain the quality of pharmaceutical products.

Requirements

High School diploma or equivalent required.
Knowledgeable of regulatory requirements and quality principles.
Minimum of two (2) years’ experience in a regulated environment.
Demonstrated ability to follow detailed SOPs and utilize good documentation practices.
Experience with good documentation practices.
Must be able to work in a team environment.
Must be detail orientated.
Must have effective verbal and written communication skills.

Nice To Haves

Associate/Bachelor’s Degree in related field preferred.
Experience in FDA pharmaceutical or medical device regulated environment.
Experience with SAP preferred.
Strong organizational skills.

Responsibilities

Support QA Specialist with obtaining temperature data for incoming Right Now Inventory (RNI) returns.
Perform QA secondary inspection of product returns at the Texas distribution center.
Support internal quality audits and assist in audit preparation and documentation.
Conduct incoming inspections of components for RNI per approved inspection plans.
Perform outgoing inspections for RNI equipment in accordance with approved inspection plans.
Review logbooks for FFF Enterprises and RNI to verify completeness and accuracy.
Conduct real-time process and operations audits to ensure procedural accuracy and personnel compliance.
Assist with maintaining Operations and Quality Assurance SOP training program.
Support supplier controls by maintaining required documentation for approved suppliers and performing periodic reviews per SOPs.
Assist Operations with root cause investigations and implementation of corrective actions.
Contribute to the execution, maintenance, and continuous improvement of the Quality Management System (QMS).