The Quality Assurance Specialist, reporting to a Quality Engineer, will support Production/Manufacturing processes by maintaining quality system compliance in a regulated environment on a day-to-day basis.
- Assigned as direct QA support to production/manufacturing of ArcherDX RUO assay components and processes.
- Support of other Production-related activities including raw materials receipt/transfer/release, labeling verification, kitting verification, QC report review, shipping verification, etc.
- Timely review of batch records (Travelers) and product release.
- Assists with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.
- Assists in managing equipment, including installation and monitoring of maintenance and calibration
- Assists Quality Engineers with audit response and follow up on required actions.
- Assists with the management of Nonconformance reports, and Corrective and Preventive Actions reports, and complaints.
- Maintain compliance with all company policies, quality systems, and procedures.
- Perform other duties as assigned by supervisor.
- 2+ years of experience within quality assurance in a medical device industry. (Pharma/biotech are acceptable).
- Experience with FDA 21 CFR 820 and ISO13485 regulations.
- Attention to detail and ability to follow directions in modifying the documentation
- Ability to interact and collaborate with multiple disciplines, and communicate clearly and effectively verbally and in writing
- Ability to work with minimal direction, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
- Bachelor’s Degree in a scientific field