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Quality Assurance Specialist Contract: Thousand Oaks, California, US
Salary Range: 35.00 - 39.00 | Per Hour
Job Code: 357297
End Date: 2025-02-06
Days Left: 26 days, 2 hours left
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About the Role: - We are looking for three candidates to join our team in a remote position, working in any timezone. The ideal candidate will have at least 5 years of experience with quality management systems.
- Experience with Veeva is a nice-to-have, and candidates with previous experience at will be heavily prioritized.
- The primary responsibility of this role is to support the product complaint system at by triaging product complaints and managing Level I complaint processing and closure in adherence with Complaint policies and procedures, while ensuring compliance with federal regulations.
Responsibilities: - Accurately enter complaints into the complaints database in a timely manner
- Triage complaints to determine complaint code and investigation level
- Determine if the complaint is associated with an adverse event or medical device
- Document follow-up communication with complainants for additional information or complaint sample returns
- Re-assign complaints to the appropriate investigation site
- Close complaints per required timeframes and provide responses to the complainant
- Work with other departments, contract partners, and call centers to resolve discrepancies/deficiencies
- Prioritize complaints and ensure accurate data entry within required timeframes
- Notify appropriate parties upon receipt of complaints
- Support the complaints returns process by determining follow-up required for complaint return samples and documenting communication attempts
- Partner with call centers providing tactical oversight and support
- Provide written communication to senior management and team members Perform other duties as assigned by supervisor
Education Qualification: - 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
Required Skills: - Project management skills including detailed note-taking, planning, scheduling meetings/workshops, presentation creation, metric analysis, and reporting
- Excellent written and verbal communication skills in English and Spanish
- Ability to work in a team-oriented, matrix environment and effectively collaborate with diverse departmental groups -
- Ability to manage a large number of complex projects simultaneously
Preferred Qualifications: - 5 years of biopharmaceutical experience in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
Pay Range: $35 - $39/hr.
Job Requirement - Quality Assurance Analyst
- Quality Assurance
- QA
- Bio
- Pharma
- biopharmaceutical
- Pharmaceutical
- pharmaceutics
- regulatory
- medical device
- investigation
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Job Tags
Hourly pay, Contract work, Remote job,