Senior QA Document Control Specialist
- Townsend Street, Lehi, UT, us
The Senior QA Document Control Specialist is responsible for the organization’s Quality Assurance Document Management Processes. The person will assist in the management of Controlled Documents supporting GxP programs at Ancestry in compliance with appropriate regulations, guidelines, procedures and protocols. The incumbent is also responsible for managing QMS-specific internal procedures, external vendor documentation, audit reports, and submission documents. (This job is open for San Francisco, CA or our Lehi, UT location.)
- Manage all aspect of Ancestry’s GxP training program including the distribution of training records, filing of completed records, oversight of training compliance, and periodic auditing of training records.
- May provide backroom audit support.
- Support management of legacy paper record retention and retrieval.
- Maintain GxP related quality system master and historical SOPs including routing of new and revised procedures according to established timelines, editing of documents based on stakeholder feedback, management of effective and obsolete records.
- Manage/conduct internal quality audits on document management related processes and procedures.
- Manage incoming external documentation from CMOs including master batch files and executed batch files, raw data, method validation protocols and reports, stability and release testing data, study protocols and reports, specifications, and other controlled documents as required.
- Assist to manage the deviation, change control, and CAPA systems.
- Assist in collaboration of Design Control document deliverables.
- Assist with tracking cGMP compliance audit trends and group metrics.
- Assist with the archival of all quality related records including audit reports, management reviews, and product reviews.
- Document and communicate decisions and issues throughout process for visibility.
- Maintain and demonstrate understanding of global medical device and in vitro diagnostic device standards and regulations.
- Assist new users in using the change control/document control system.
- Attention to detail, time management coordination skills, ability to multitask day to day activities.
- Performing other duties as assigned or required.
- Bachelor degree or equivalent in a technical area. Bachelor’s degree is highly preferred.
Background & Experience:
- Three (3) years of progressive global quality assurance background in In Vitro Diagnostics (IVD) and medical device industries, with a hands-on role in quality operations and quality systems
- Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, CFR 809 (IVDD), ISO 13485, etc.
- Experience with performing Internal and Supplier Audits a plus
- ASQ (American Society for Quality) certifications a plus
- Experience with MasterControl a plus
Ancestry is a profitable, growing company with a positive, high-energy environment. Together, our dedicated teams are harnessing the power of technology and using it to simplify the way people connect with their families and their unique legacies. Our work environment is fast-paced and challenging, but also extremely exciting. You’ll work with a team of passionate, engaged individuals. We offer excellent benefits and a competitive compensation package. For additional information, regarding our benefits and career information, please visit our website at http://ancestry.com/careers
Ancestry is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at Ancestry via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Ancestry. No fee will be paid in the event the candidate is hired by Ancestry as a result of the referral or through other means.
Ancestry is an Equal Opportunity Employer that makes employment decisions without regard to race, color, religious creed (including religious dress and grooming practices), national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and medical conditions related thereto), sexual orientation, gender, gender identity and expression, age (40 and older), mental or physical disability (including HIV and AIDS), medical condition (cancer and genetic characteristics), veteran status, citizenship, marital status, genetic information, or any other basis that is prohibited by applicable law. The Company also makes reasonable accommodations to applicants or employees with qualifying disabilities who request them and who otherwise meet the requirements of applicable law. If you would like to request an accommodation during the application process, please contact our Director of Recruiting.
All job offers are contingent on a background check screen that complies with applicable law. For San Francisco office candidates, Ancestry will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of San Francisco's Fair Chance Ordinance.