Quality Assurance Specialist
Posted on: May 7, 2021
Job Overview: Covance by Labcorp is currently hiring for a
Quality Assurance Specialist to join our growing team in
Morrisville, North Carolina. The Senior Quality Engineer is
responsible, under Director level supervision, for leading,
supporting and ensuring continued suitability of the Quality
Management System (QMS) with a primary focus on design control,
validation, risk management, supplier management, process control,
post-market surveillance, complaint handling, CAPA, auditing,
change control, document control and training.
- Relocation Assistance availible* Essential Duties and
- Ensure that the Quality System is compliant with domestic and
international quality system regulations (21 CFR 820; ISO
- Promote awareness of the Quality System and provide training to
individuals across the organization on quality management
principles, tools, techniques and best practices.
- Support the implementation of corporate policies and procedures
relating to quality, design control, risk management, project
management, process development, supplier management and FDA/ISO
- Engineer solutions to address product and process quality
issues. Work as part of a team to drive forward continual
improvement initiatives and address compliance challenges.
- Support the research, development and manufacturing of in-vitro
diagnostic (IVD) medical device products. Lead the planning,
design, preparation, execution, reporting, and analysis of design
verification and validation efforts to qualify materials, tools,
equipment, systems, processes, and software used in the testing,
processing, manufacturing, storing, and distribution of IVD
- Initiate and coordinate the inspection and testing of raw
materials, work-in-process, finished goods and environmental
- Design and develop forms, instructions and sampling procedures
for recording, evaluating, and reporting quality and reliability
- Manage and maintain design history files, risk management files
and device history records to ensure design and development
activities are executed as required.
- Coordinate and support the Corrective / Preventive Action
(CAPA), Change Control and NCM/MRB systems.
- Support the document control and training system.
- Lead the investigation, reporting, and resolution of customer
- Conduct supplier audits and partner with suppliers to address
Requests for Supplier Corrective Action (RSCA).
- Coordinate and support the annual audit program; manage,
schedule, perform and report on internal, external and supplier
- Compile and report quality metrics. Assess and report
post-market surveillance data in accordance with regulatory
- Bachelor's Degree in Biology, Chemistry, Life Sciences or
Engineering required, Master's Degree preferred.
- At least 3 years of experience in a quality role supporting
clinical research, pharmaceutical development or IVD
- Note: An advanced degree in Biology, Chemistry or Life Sciences
accepted in lieu of professional experience.
- ASQ Certified Quality Engineer and Six Sigma Black Belt
- Thorough understanding of quality philosophies, principles,
systems, methods, tools and standards
- Through understanding of customer expectations, supplier
relations and continual improvement practices
- Experienced in acquiring and analyzing process data using
appropriate quantitative and statistical methods across a spectrum
of business environments to facilitate process improvement
- Excellent communication skills
- Excellent writing skills
- Strong organizational skills
- Ability to handle multiple projects simultaneously
- Exhibits self-reliance in managing personal workload and
schedule of deliverables
Keywords: Covance, Durham , Quality Assurance Specialist, Other , Durham, North Carolina
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