Quality Assurance Specialist II/III (Production Manufacturing QA) at ArcherDX
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.
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 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.
- 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
In Colorado, our competitive compensation package includes a base salary starting from $69,000. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.