Document Control Coordinator
Company: HealthFirst
Location: Mukilteo
Posted on: March 18, 2023
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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
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