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Specialist - Quality Assurance (Mid Level)
Job Description
Morning Shift (Mon to Fri)
What you’ll do
•Execute the triage, investigation, and closure of product quality complaints.
•Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.
•Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.
•Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations;responsible for documentation of objective evidence in QMS records.
•Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers
Who you are
•Bachelor’s degree required;additional training/education preferred through ASQ (or relevant society) and/or Master’s level program
•Minimum 3 to 7 years relevant experience industry experience (e.G. GMP medical device, pharmaceutical) required
•Minimum 3 to 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
•Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance
•Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints
4 skills needed, Pharma background, quality Management Systems, Technical Writing and complete management experience
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
Anju Abel's leadership has been instrumental in transforming LanceSoft's global staffing operations. Her focus on innovation, employee satisfaction, and client-centric delivery has led to higher retention rates, a motivated workforce, and enhanced operational efficiency.
"This award is a testament to the incredible team at LanceSoft and our unwavering commitment to redefining staffing solutions," said Anju Abel. "I'm honored to receive this recognition and proud of the impact we continue to make in the lives of our clients and talent worldwide."
The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.