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Quality Complaints Senior Associate

The Steely Group

Thousand Oaks, CA

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Continuous Improvement, Cross-Functional, Data Analysis, Detail Oriented, Documentation, Establish Priorities, GMP (Good Manufacturing Practices), Healthcare Quality, Lift/Move 50 Pounds, Maintain Compliance, Manufacturing, Mathematics, Medical Equipment, Multitasking, Operational Audit, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Product Management, Product Testing, Project/Program Management, Quality Assurance, Radiography, Regulatory Compliance, Resolve Customer Issues, Spreadsheets, Support Documentation, Team Player, Technical Analysis, Time Management, Trend Analysis, Word Processing, Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
19 days ago

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

About the Company

T

The Steely Group

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