Quality Assurance Associate.
Position Overview.
This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s short- term goals and objectives as it relates to quality assurance.
The Quality Associate assists the Quality team in support of all Quality Systems activities by generating quality reports (metrics, trending, etc.), assisting with Internal/External Audit activities, CAPA, Supplier Management, complaint handling, and providing back-up system administrator role for Document Control and Training. The Quality Associate will have responsibility for the NMR system including generation, root cause analysis and determining corrective action in collaboration with required teams throughout processing and manufacturing. The Quality Associate actively participates in the qualification and on-going support of Grand Avenue, or equivalent, quality systems software.
Essential Duties & Responsibilities
- Ownership of NMR system including issuance, initiation, coordination of root cause analysis as well as corrective action where required, and ensures proper filing of all records. The Quality Associate will ensure all non-conforming material is quarantined and segregated per procedure where required. Ensure NMR is routed to appropriate parties for disposition and final approval.
- Includes responsibilities of a Quality Assurance Technician where manufacturing requires inspection. Inspection activities include but are not limited to: Incoming inspection of product and components, inspection of product during processing, in-process testing including pull strength and tensile strength testing and final product inspection and release.
- Assist Quality Management with the Internal Audit Program. This may include acting as an Assistant Internal Auditor when assigned audit duties, assisting with audit scheduling, and coordinating follow-up corrective and preventive actions and supporting documentation.
- Assist Quality Management with the CAPA Program. This may include completing corrective and preventive actions under the direction of Quality Management and/or coordinating actions with other area management.
- Assists with maintenance of Supplier Management Files and the Approved Supplier List where needed. Initiate Supplier Evaluations and obtain supporting evidence such as contracts, ISO/Quality certifications, supplier surveys, and audit reports.
- Assist Quality Management with the qualification and on-going support of Grand Avenue Software modules and verification/validation of software generated LHRs. Run test scripts for software verification/validation as needed. Perform the day-to-day system administrator activities associated with Document Control and Training as a backup within Grand Avenue.
- Organize and maintain Quality System Records in the Document Control Room and in off-site archives. Assist maintenance for all Quality System Logs and Training Profiles.
- Participate in the identification of issues and initiation of actions to prevent the occurrence of any nonconformity relating to products, processes, or the quality system.
- Assist Quality in generation of monthly and quarterly trend reports where required.
Education
- BA or BS degree required. A degree in Quality, Life Science, a Physical Science, or Engineering is preferred.
Experience and Skills
Work Experience Required:
- 3 years of work experience in the Medical Device, Pharmaceutical, or Life Sciences/Medical Industry is preferred. Previous Quality Systems experience is a plus. A combination of advanced coursework and internships may be used to fulfill this requirement.
- Experience in the use of electronic document management systems is required.
Specialized Skills, Knowledge:
- Familiar with FDA QSR and ISO 13485 requirements.
- Proficient in MS Office applications (Word, Excel, PowerPoint, Visio).
Certification Requirements:
- None required
- ASQ Certified Quality Auditor preferred but not required.
Physical Requirements
- Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
- Ability to distinguish colors.