Senior Analyst, Quality Documentation
Company: Disability Solutions
Location: Santa Rosa
Posted on: May 6, 2024
Job Description:
Biosense Webster is recruiting for a Senior Analyst, Quality
Documentation to be located in Santa Rosa, CA. The Senior Analyst,
Quality Documentation is responsible for maintaining quality
management system documentation that meets regulatory, quality and
company requirements. This position will oversee the training
program as well as the complete document lifecycle, including
creation, review, approval, distribution, training, retrieval,
archival and obsolescence to ensure full compliance. At Johnson &
Johnson, we believe health is everything. Our strength in
healthcare innovation empowers us to build a world where complex
diseases are prevented, treated, and cured, where treatments are
smarter and less invasive, and solutions are personal. Through our
expertise in Innovative Medicine and MedTech, we are uniquely
positioned to innovate across the full spectrum of healthcare
solutions today to deliver the breakthroughs of tomorrow, and
profoundly impact health for humanity. Learn more at
https://www.jnj.com/. Are you interested in joining a diverse team
delivering outstanding results to our customers? Apply now for this
exciting opportunity! Key Responsibilities:
- Responsible for the document change management process,
ensuring that company documents are routed, reviewed, approved,
controlled, and implemented in accordance with established
procedures.
- Process Document Change Requests (DCRs) and ensure that all
comments/corrections submitted against a document are communicated
and successfully resolved or work with the correct departments for
resolution before document is published.
- Review new and revised controlled documentation for appropriate
format, content and consistency with other documentation and
compliance to document control procedures.
- Reviews, edits, and formats, controlled documents according to
approved procedures and templates, monitors document status and
approval notifications, distribution, and archiving.
- Maintains revision and approval status of all controlled
documents.
- Create and maintain document approval matrix to be used as
baseline for document approvals.
- Ensure the management of controlled documents are processed in
a timely manner while safeguarding quality, accuracy and adherence
to company and regulatory requirements.
- Collaborate with cross-functional departments to ensure timely
implementation of document change requests and change control
associated tasks.
- Ensure compliance with established document control and record
retention procedures.
- Maintain the document control system, including formatting,
numbering, record retention and change control.
- Maintain filing and archiving of paper and electronic
records.
- Develop document templates, standards, and conventions.
- Responsible for issuing, completing, closing, and archiving
controlled documentation (including lab notebooks, logs, forms,
procedures, test me, specifications, batch documentation and labels
and maintain issuance log).
- Assure applicable site personnel are adequately trained in the
policies and procedures of the document control system.
- Oversee the training program and ensure compliance with
regulations, procedures, and best industry practices.
- Partner with cross-functional department leads to create and
maintain employee training plans.
- Support improvement initiatives to strengthen document
management and employee training processes and systems.
- Support internal and external audit activities.
- Develop and report on KPIs / metrics for Document Control and
Training programs.
Keywords: Disability Solutions, Santa Rosa , Senior Analyst, Quality Documentation, Professions , Santa Rosa, California
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