Specialist Quality Complaints job in Thousand Oaks
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California (CA),
Thousand Oaks
| Job Code: | 24-01327 |
| Employer: | Aequor |
| Category: | Chemistry |
| Location | |
| Country: | United States |
| State: | California (CA) |
| City: | Thousand Oaks |
| Post Date: | 05/10/2024 |
| Description | |
|
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 1. 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. 2. Candidate will also be responsible for working with other *** departments, contract partners and call centers to resolve discrepancies/deficiencies. 3. 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 | |
ref: (24-01327) 11 days ago
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