THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Support product and non-product software projects to continuously evaluate compliance, validation efforts, and effectiveness.
- Interface with functional department leads to identify product and non-product software gaps, improvements, and oversee the validation and software performance to insure the product and non-product software and processes meet quality requirements/standards.
- Execution will include collaborating, via review and authoring of documents, with Archer’s product and non-product software used to support product verification, manufacturing, process validation, clinical data collection/data management and in the creation of software documentation to support validated software design, development, verification and review by regulatory authorities. Where appropriate, interface with external resources, such as consultants, on key initiatives with management on timelines, costs and execution.
- Support product and non-product software risk assessment, cybersecurity design considerations, development of software user needs and requirements, validation test protocol authoring and execution, and software configuration management.
- Support product and non-product software execution of validation supporting IT infrastructure such as Archer’s MES, ERP, eQMS software, clinical data collection systems & analysis software, and clinical data storage. Work with key stakeholders among Archer’s IT, data management and clinical teams and support validation of data integrity, security, audit readiness, privacy (HIPAA, GDPR, etc.), data retention, storage and recovery. Support improvement of Archer’s quality and compliance for product and non-product software and tools
- Assess Archer’s infrastructure needs to create and execute and validation planning to ensure proper support for Archer’s non-product software and infrastructure needs.
- Support product and non-product software audits, as a subject matter expert, when working with external business partners and regulatory authorities. When assigned findings for closure, demonstrate accountability and a commitment to continuous improvement by resolving issues.
- Perform other duties as assigned by supervisor.
- Minimum of 3 years in software testing to support software used in a regulated industry, with 3 or more years of experience in software quality assurance and/or software tool validation.
- Demonstrable experience in performing software risk assessment, software validation & testing. Good technical writing skills with hands-on experience authoring, peer-reviewing and defending software documentation for non-product, test data infrastructure and non-product tools.
- Ability to speak and defend software validation documentation to external auditing authorities.
- Certifications, such as ASQ, in quality assurance preferred.
- Ability to interact with multiple disciplines and communicate clearly and effectively verbally and in writing.
- Ability to work independently and utilize good problem-solving skills.
- Ability to multitask and work within a fast-paced dynamic team environment. Archer is interested in a subject matter expert who will build collaboration among key departments rather than define functional boundaries.
- Desired experience and standards knowledge for the following: 21 CFR Part 11, ISO 13485, ISO 14971, 62304, GAMP, GDPR, HIPAA, Cybersecurity
- Minimum B.A. or B.S., preferably in engineering or other technical discipline