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.
The Document and Records Supervisor is responsible for ensuring compliant and efficient storage of records and management of change to those records. This position is the champion of the eQMS document repository and manages the document control team while establishing best practices for records retention and management.
- Maintain a document control team utilizing both static and flexible resources to meet business needs for document generation, revision, storage and organization.
- Ensure consistent access and business continuity regarding Archer’s eQMS system for managing quality records, validated quality processes and related backups.
- Collaborate with partners within the quality department to optimize use of tools and records for easy demonstration of our quality system’s performance.
- Perform a key role in supporting audits and inspections by speaking to the compliance of Archer’s maintenance of quality records and ensuring the audit team has easy access to all other documents needed for review by auditors and inspectors.
- Collaborate with partners on Archer’s business continuity and disaster recovery plans.
- Conduct, or provide content on, training on document control and good document practices for all employees.
- Minimum 4 years of experience in quality engineering, document control or a related role.
- One or more years of experience managing direct reports and resolving both employment issues as well as escalations from functional partners.
- Strong working knowledge of 21 CFR 820 and ISO 13485:2016.
- Collaborative and positive attitude.
- Working knowledge of global regulatory submissions and typical content included therein.
- Direct experience being interviewed in inspections and audits, and familiarity with audit support practices.
- Minimum Bachelor’s degree.