Position Summary

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.

Essential Functions and Duties

• 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).

Education, Knowledge, Skills and Experience

Required Education:

• High School diploma or equivalent required.
• Associate/Bachelor’s Degree in related field preferred.

Required Knowledge:

• Knowledgeable of regulatory requirements and quality principles.

Required Experience:

• 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.

Preferred Experience:

• Experience in FDA pharmaceutical or medical device regulated environment.
• Experience with SAP preferred.

Required Skills:

• Must be able to work in a team environment.
• Must be detail orientated.
• Must have effective verbal and written communication skills.

Preferred Skills:

• Strong organizational skills.

Physical requirements

Vision, hearing, speech, movements requiring the use of wrists, hands and/or fingers. Must have the ability to view a computer screen for long periods and the ability to sit for extended periods. Must have the ability to work the hours and days required to complete the essential functions of the position, as scheduled. Must have the ability to lift and maneuver items of at least 20 lbs. Working condition include normal office setting/warehouse.

Mental Demands

Learning, thinking, concentration and the ability to work under pressure, particularly during busy times. Must be able to pay close attention to detail and be able to work as a member of a team to ensure excellent customer service. Must have the ability to interact effectively with co-workers and customers, and exercise self-control and diplomacy in customer and employee relations’ situations. Must have the ability to exercise discretion as well as appropriate judgments when necessary. Must be proactive in finding solutions.

Direct Reports

No

EEO/AAP Statement

FFF Enterprises/NuFactor is an equal opportunity employer to all and prohibits discrimination and harassment based on the following characteristics: race, color, caste, religion, religious creed (including religious dress and grooming practices), national origin, ancestry, citizenship, physical or mental disability, medical condition (including cancer and genetic conditions), genetic information, marital status, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender, gender identity, gender expression, age (40 years and over), sexual orientation, veteran or military status, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or any state protected leaves), domestic violence victim status, political affiliation, reproductive health decision-making, and any other characteristic protected by state or federal anti-discrimination law covering employment. These categories are defined according to Government Code section 12920. The Company prohibits unlawful discrimination based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.

Acknowledgement

The above statements are intended to describe the general nature and level of work being performed by the incumbent assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and/or skills required of all personnel so classified.

The undersigned employee acknowledges receipt of the Job Description for the employee’s position and understands the essential functions, responsibilities and qualifications of the position. Furthermore, the employee acknowledges that this Job Description does not include all of the essential functions of this position, and that these essential functions may change as deemed necessary by the manager.