Remote: Specialist Quality Complaints

2 weeks ago

Thousand Oaks, United States Ronin Staffing, LLC Full time
Job DescriptionJob Description

HERE'S THE JOB DESCRIPTION: 
Title: Specialist Quality Complaints #12617 (3 openings)
Pay Rate: $41-45.50/hr
Location: Remote-Based
Length: 6 month contract + possible extension

Job Details:

  • Supporting the product complaint management system by conducting complaint investigations.

  • Processing all complaint records from end-to-end adhering with complaint policies and procedures, while assuring compliance to federal regulations

Top Must Have Skill Sets:

  • Complaint handling experience

  • Quality GMP/GLP experience experience working in a regulatory environment

  • Critical thinking skills/Organization

  • Bilingual in English and Spanish

Responsibilities:

  • 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 Amgen 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.

Basic Qualifications:

  • 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

Preferred Qualifications

  • Root Cause Analysis (RCA) investigative and deviations experience.

  • 3-4 years of Quality GMP/GLP experience and working in a regulatory environment.

  • 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

  • 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

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