Quality Assurance Specialist II/III (Production/Manufacturing QA) (ADX-261-20)
Quality Assurance Specialist II/III (Production Manufacturing QA)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
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.
RESPONSIBILITIES:
- Assigned as direct QA support to production/manufacturing of ArcherDX 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.
- May assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.
- May assist in managing equipment, including installation and monitoring of maintenance and calibration.
- May assist Quality Engineers with audit response and follow up on required actions.
- May assist 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.
QUALIFICATIONS:
- 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
EDUCATION:
- Bachelor’s Degree in a scientific field