QA Complaints Associate

Who are we?

A California based multi-National Company focused on providing consumers with the highest quality natural, holistic products for their Aroma therapy, Oral care, Health & Wellness needs. The company's products are marketed under several brands including private labelled brands for major U.S. retailers. The Products are available through reputed retailers like Walmart, Walgreens, TJMax, Burlingtons, Dollar General, Amazon.com, and Walmart.com.

What will you do?

• Process product feedback and maintain complaint handling process in compliance with applicable US FDA regulations.

• Participate in cross-functional meetings to review complaints and other post market data.

• Ensure post market feedback including complaints is processed, investigated, and closed in a uniform and timely manner in accordance to internal SOP. This will include receiving complaints, initiating complaint files, performing, and documenting complaint investigations, and taking appropriate actions to close the complaint files.

• Evaluate documentation for completeness and consistency. Assign additional actions as necessary to close the complaint file. Approve final complaint file for closure after all applicable actions are completed.

• Review and analyze lot documentation to determine if there are any anomalies that may be related to reported product failures.

• Create customer response letters. Provide peer review and feedback of complaints and reports.

• Perform/support regulatory reporting determination for complaints submissions.

• Interface with the cross functional teams and external agencies as needed for the regulatory reporting decision and submissions.

• Prepare customer communication (response letters, acknowledgement letters) as appropriate.

• Compile and provide metrics on post market data for Management Review.

• Implement and maintain electronic complaint management and reporting systems (eMDR) in compliance with FDA regulations.

• Conduct training for post market feedback and complaint handling processes.

• Support continuous improvement and corrective and preventive action when necessary to address timeliness, efficiency, and overall compliance of post market processes.

• Maintain knowledge of applicable external standards, applicable regulations, and implement new requirement into related procedures.

• Support Risk Management activities related to complaint handling and post market surveillance.

• Participate in internal audits as assigned, in accordance with approved audit schedule.

• Support company goals and objectives, policies and procedures, FDA regulations for OTC, Medical Devices, and Dietary Supplements.

• Perform other duties as necessary.

Required Qualifications

• Bachelor’s degree (or equivalent experience) in science, engineering, and/or related field with 3-5 years of related experience

• A minimum of 3 years of combined experience in post market surveillance, complaint management, event reporting and the knowledge of regulations associated with these functions is required.

• Ability to manage priorities and workflow in a rapidly changing environment * Excellent organizational, problem-solving, and analytical skills

• Excellent communications, documentation and time management skills required.

• Must be able to work with minimal supervision.

• Good interpersonal skills

• Previous experience with USP/FDA Quality audits

Preferred Qualifications

• Experience with Medical Devices, OTC, and Dietary Supplements, in a regulatory environment

• Working knowledge of basic quality systems regulations such as QSR and ISO.

• Proficient technical writing skills and use of documentation programs (Example Office Windows, Excel, Access, Power Point, etc.).

• Working knowledge of fundamental quality and statistical tools

• Possess excellent interpersonal and communication skills with the ability to develop trust, respect, and confidence with internal and external customers.

• Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards.

Office Environment

• Must be able to remain in a stationary position and operate office equipment for a prolonged period.

• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.

• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.

• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• Bonus pay

Application Question(s):

• Do you have working knowledge of cGMP, GDP, GLP?

Experience:

• AQL inspections: 3 years (Required)
• FMCG: 3 years (Required)

Work Location: One location