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Quality Complaints Senior Associate
Job Description
Our client is seeking a dedicated and detail-oriented Quality Complaints Senior Associate to join a dynamic team focused on maintaining the highest standards in life sciences and medical device quality assurance. The successful candidate will play a crucial role in managing product complaint evaluations, ensuring accurate documentation, and supporting continuous improvement initiatives, all in a fast-paced GMP environment.
Key Responsibilities:
- Receive, clean, and evaluate product complaint return samples, including photographs, x-rays, and written inspections.
- Interface with various company sites and business partners to coordinate sample evaluation and management.
- Manage complaint return sample inventory to ensure accuracy and accessibility.
- Author detailed technical assessment reports based on sample evaluations and inspection findings.
- Prepare shipment inventory for delivery to the Mail Center, ensuring timely and accurate dispatch to patients or stakeholders.
- Collaborate cross-functionally to support complaint resolution and quality documentation efforts.
- Maintain compliance with regulatory and company standards during all processes.
- Support continuous improvement initiatives by analyzing data trends and contributing insights.
Qualifications:
- Bachelor's Degree in Life Sciences or a related field, or an equivalent combination of education and experience.
- Typically 1+ years of relevant quality assurance or manufacturing experience in GMP pharmaceutical or medical device industries.
- Proficiency in evaluating documentation and operational procedures according to established guidelines.
- Self-motivated, detail-oriented, with strong organizational and time management skills to prioritize multiple tasks and meet deadlines.
- Basic statistical and mathematical skills, including data trending and analysis.
- Basic project management skills to coordinate tasks effectively.
- Excellent written and verbal communication, along with collaboration skills.
- Strong proficiency in word processing, database, and spreadsheet applications.
- Ability to work independently while adhering to instructions and guidelines.
- Physical ability to perform tasks such as prolonged sitting and standing, lifting boxes or containers up to 50 lbs, and transporting samples across the campus.
Work Location:
Onsite - Thousand Oaks, California
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