Document Control Coordinator

Company: HealthFirst
Location: Mukilteo
Posted on: March 18, 2023

Job Description:

At HealthFirst, we provide solutions that integrate technology, products and services with the latest regulatory knowledge, enabling healthcare providers worldwide to effectively meet their evolving compliance obligations. HealthFirst's success is driven by our team of uniquely capable people whose similarities and differences make us who we are. We are committed to providing excellent customer service experiences and compliance peace of mind.HealthFirst is seeking a Document Control Coordinator in their QA department to join the team. This role will be responsible for processing, maintaining, and record management of the company's GMP document control system while also ensuring the accuracy, quality, and integrity of the content. This individual will ensure company adherence to required training's and will be responsible for the maintenance of all controlled documentation within the electronic document control system among other duties and responsibilities. This is an excellent opportunity for an individual who is looking to advance in a Quality Assurance role. Primary Job Responsibilities:Act as an admin for the document management software.Assist with document migration and organization from the existing document management system to the new document management system.Execute document approval, release, archival, and obsolescence, per the Quality System.Assist with reviews and edits to SOPs as needed.Review documents per Good Documentation Practices compliance.Provide document support for internal and external audits, as needed.Manage changes to the quality system documents and work with SMEs and process owners for collaborations. May lead and provide training associated with the understanding and management of Quality System.Responsible for the routine maintenance of active and archived controlled documents and records in accordance with department SOPs.Responsible for checking the "Document control mailbox for Change Requests and other related requests daily.Manage and maintain off-site storage, document retention and retrieval of documents per department SOP.Support any training needs regarding the quality system documents in collaboration with HF's learning and development system.Perform Document Control metric reporting and analysis for the local site data.This position assumes and performs other duties as assigned. Requirements:A minimum of 3 years of Quality Management System, Document Control, and Records Management in a biotech, Medical Device, or pharmaceutical industry.Strong understanding of QMS, and Good Documentations Practices per 21 CFR requirements. Experience with multiple document management and eQMS systems preferred.Proficiency in Windows applications, (Word, Excel, and PowerPoint).Experience working in Smartsheet desired Strong Communication Skills (written and verbal).Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment.Must be able to work independently with minimal supervision and in a team-oriented environment.High attention to detailHealthFirst thanks our dedicated team members by offering a competitive base salary and incentive plan, a comprehensive benefits package that includes medical, dental, vision, disability, life insurance, 401k, tuition reimbursement, 20 days of PTO to start, and much more!HealthFirst is an equal opportunity employer and does not discriminate against applicants or employees based on race, color, religion, creed, national origin, ancestry, a disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Keywords: HealthFirst, Seattle , Document Control Coordinator, Other , Mukilteo, Washington