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Specialist Quality Complaints

Thousand Oaks, CA
Description:
Note:
  • 100% REMOTE - no time zone preference.
  • 3 HEADCOUNT NEEDED

Ideal Summary:
  • Prefers a bachelors degree or higher. Someone who has Root Cause Analysis (RCA) investigative and deviations experience.
  • Experience 3-4 YOE Quality GMP/GLP experience and working in a regulatory environment. Processing all complaint records from end-to-end. Someone who can pick up quickly.
  • Problem Solving, Analytical thinker. Great computer skills, willing to learn internal systems.

SUMMARY
Primary responsibilities include: 
  • Supporting the product complaint management system at by conducting complaint investigations. 
  • Processing all complaint records from end-to-end adhering with Complaint policies and procedures, while assuring compliance to federal regulations.

FUNCTIONS
  • Candidate will be responsible for; ensuring complaints are accurately entered into the complaints database in a timely manner, complaints are assessed according to SOP's, escalates issues related to nonconformance, manages timely communication and follow-up of critical complaints, generate and distribute customer response letters.
  • Candidate will also be responsible for working with other departments, contract partners and call centers to resolve discrepancies/deficiencies.
  • Additional responsibilities include prioritizing complaints and understanding the importance of accurate data entry of complaints within the required timeframe, notifying appropriate parties upon receipt of complaints, supporting the complaints returns process by determining follow-up required for complaint return samples and documentation of communication attempts, partnering with call centers providing tactical oversight and support, providing written communication to senior management and team members, and performing other duties as assigned by supervisor. Doctorate degree.
  • OR
  • Master’s degree & 3 years of experience directly related to the job
  • OR
  • Bachelor’s degree & 5 years of experience directly related to the job

COMPETENCIES/SKILLS
  • Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
  • Excellent written and verbal communication skills in English and Spanish.
  • Excellent verbal diction and ample vocabulary is necessary as Specialist will interact with patients to obtain additional information on reported events and sample returns.
  • Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups
  • Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
  • Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.
  • Candidate must possess outstanding attention to detail and organization skills, effective decision.

Basic Qualifications
  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.

Top 3 Must Have Skill Sets:
  • Complaint handling experience
  • Quality GMP/GLP experience experience working in a regulatory environment
  • Critical thinking skills/Organization
Pay Rate  between $42 - $47/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"

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