Analyst, Quality Documentation

4 weeks ago

Santa Rosa, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking an Analyst, Quality Documentation for a long-term engagement at one of our Global Medical Device Manufacturing clients located in Santa Rosa, CA.



Our client is a clinical-stage medical device company advancing transseptal left atrial appendage (LAA) closure. This role is a full-time, fully benefited position. As a Kelly employee, you will be eligible for our enhanced benefits, 50% paid Medical & Dental, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly employees in this group receive annual performance reviews


.
Analyst, Quality Documentatio


n
The Analyst, Quality Documentation is responsible for maintaining a Document Control system that meets regulatory, quality and company requirements. Activities will include but are not limited to, word processing, distributing, and maintaining documents and records both manual and within the Electronic Quality Management System (eQMS


).
Description of

  • WorkOversee the complete document lifecycle, including creation, review, approval, distribution, training, retrieval, and obsolescence to ensure full complia
  • nce.Reviews, edits, and formats, controlled documents according to approved procedures and templates, monitors document status and approval notifications, distribution and archiv
  • ing.Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedu
  • res.Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated ta
  • sks.Ensure the management of controlled documents are processed in a timely manner while safeguarding quality, accuracy and adherence to company and regulatory requireme
  • nts.Maintains revision and approval status of all controlled docume
  • nts.Responsible for issuing, executing, closing and archiving controlled documentation (including lab notebooks, logs, forms, procedures, test methods, specifications, batch documentation and labels and maintain issuance l
  • og).Assure applicable site personnel are adequately trained in the policies and procedures of the document control sys
  • tem.Oversee the training program and ensure compliance with regulations, procedures, and best industry practi
  • ces.Support the maintenance of the document control system, including formatting, numbering, record retention and change cont
  • rol.Support improvement initiatives to strengthen document management processes and syst
  • ems.Assist in development and use of document templates, standards, and conventi
  • ons.Maintain filing and archiving of paper reco
  • rds.Issue and manage electronic records in the e


QMS.
Required Skills & Exper

  • ienceBachelor’s degree or equivalent education and work experie
  • nce. Minimum 3 years of experience providing document management and record control in an FDA-regulated environment, preferably medical device manufactu
  • ring.Knowledge of U.S. FDA medical device regulations (21 CFR 820) and/or International Standards (ISO 13
  • 485).Experience using electronic Quality Management System solutions in a regulated environ
  • ment.Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution ski
  • lls. Ability to make decisions and recommendations related to the
  • role.Strong ability to multi-task and to meet business deadl
  • ines.Excellent organizational skills with an ability to think proactively and prioritize
  • work.Ability to work with minimal supervi
  • sion.Demonstrated experience with Microsoft Office suite and Adobe Acr


obat.
Important informa

tion: Applicants must be legally permitted to work in the United States immediately and without employer sponso


rship.

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