Associate I, Quality Assurance

About the Role

The Quality Assurance Associate I ensures compliance with all policies and procedures at the local distribution center to protect and maintain the quality of pharmaceutical products.

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).

Requirements

• High School diploma or equivalent required; Associate/Bachelor’s Degree in related field preferred.
• Minimum of two (2) years’ experience in a regulated environment.
• Demonstrated ability to follow detailed SOPs and utilize good documentation practices.
• Knowledgeable of regulatory requirements and quality principles.

Skills

• Must be able to work in a team environment.
• Must be detail-oriented.
• Must have effective verbal and written communication skills.
• Strong organizational skills (preferred).

Physical Requirements

• Vision, hearing, speech, and movements requiring the use of wrists, hands, and/or fingers.
• Ability to view a computer screen for long periods and sit for extended periods.
• Ability to lift and maneuver items of at least 20 lbs.
• Ability to work the hours and days required to complete the essential functions of the position, as scheduled.

Working Conditions

• Normal office setting/warehouse.

Mental Demands

• Learning, thinking, concentration, and the ability to work under pressure, particularly during busy times.
• Ability to pay close attention to detail and work as a member of a team to ensure excellent customer service.
• Ability to interact effectively with co-workers and customers, exercising self-control and diplomacy.
• Ability to exercise discretion and appropriate judgments when necessary.
• Proactive in finding solutions.

Preferred experience includes work in an FDA pharmaceutical or medical device regulated environment and familiarity with SAP.