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.

POSITION SUMMARY:  

The Quality Assurance Specialist, reporting to a Quality Engineer, will support Personalized Cancer Monitoring (PCM) Manufacturing Quality activities in an ISO 13485 and GMP-regulated environment.  The individual must have a strong knowledge and application of the CFR and cGMP regulations to support the product launch.

 RESPONSIBILITIES:

• Provide direct QA support to Manufacturing Operations and process development for the ArcherDX PCM assay components and processes.
• Review and approve batch records (Travelers) for product release.
• Assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.
• Support the creation of Standard Work, Line Balance, Work Content, and other analytical tools, and work with production teams to implement
• Ensure the Quality System elements are in compliance with the regulations, and help to create and/or drive improvements in the creation of Standard Operating Procedures for the manufacture of the new product
• Collaborate across Development, Operations, and Manufacturing teams to support actions that help ensure production readiness for new products
• Provide QA support to create and maintain the production process in a validated state
• May support other Production-related activities including: raw materials receipt/transfer/release, labeling verification, kitting verification, QC report review, etc.
• Perform other duties as assigned by supervisor

QUALIFICATIONS:

• 2+ years of experience within quality assurance in (life sciences) medical device.
• Experience with 21CFR820, cGMP, and ISO13485 regulations.
• Knowledgeable of New Product Development activities and technology transfer to production in a regulated laboratory or manufacturing environment
• Experience supporting and conducting process validations
• Lean/Six Sigma Certification preferred
• Attention to detail and ability to follow directions in modifying 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

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.