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Senior Document Control Specialist

$28 - $32 per hour

Experis/Manpower Group

Title: QA Specialist/Documentation Specialist
Location: San Diego, California (100% Onsite)
Duration: 3+ Months (Possibility to extend)
Shift Time: 8am to 5pm
Pay Range : $28/hr to $32/hr (On W2)

We are looking for a "QA Specialist/Documentation Specialist " to join one of our Fortune 500 clients.

Job Responsibilities:
  • Perform the role of Change Order Coordinator for the facility.
  • Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release of documents in a timely manner.
  • Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
  • Issue document numbers, lab notebooks numbers and part numbers.
  • Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
  • Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
  • Perform Document Control training for new and existing employees.
  • Support development of QA-related training materials.
  • Assist with training assignment and collection of training metrics in Metro.
  • Trend Document Control Metrics for Management Review.
  • Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
  • Assist with internal and external audits.
  • Support the continuous improvement to the Quality Management System, with a specialty focus on document control and change order processes.
  • Qualifications:

  • Bachelor's Degree and/or an equivalent combination of education and experience.
  • 2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
  • Working Knowledge of 21CFR820, ISO 13485:2016 standard.
  • Experience processing changes using an electronic documentation system.
  • Experience with technical writing, formatting and trending of data.
  • Agile Document Management System experience preferred.
  • Competencies:

  • Proficient with Microsoft Office, including Word, Excel, PowerPoint, electronic document control tools and Visio.
  • Ability to understand QMS procedures and ability to recognize deviations from approved documented procedures
  • Self-starting, detail oriented, and ability to focus on task at hand
  • Ability to work independently with multiple departments to resolve Document Control issues
  • Must be able to work effectively in a fast paced, team-oriented environment
  • Well-developed English written and verbal communication skills.

We are looking for the candidate who are eligible to work with any employers without sponsorship .

If you're interested, please click "Apply" button
Vacancy posted 3 hours ago
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