Valeant Pharmaceuticals

  • Sr. Documentation Analyst

    Job Location US-WA-Bothell
    Job ID
    10428
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Responsibilities

    • Administer the Agile Change Order, Manufacturing Change Order, and Deviation processes including initiation, checking, routing, releasing, implementing, and transferring to the ERP system
    • Coordinate with other disciplines to ensure change orders are complete and meet documentation requirements prior to routing
    • Coordinate with other disciplines to ensure change order implementation actions are complete; monitor and report on action status
    • and report on action status
    • Chair Change Control Board (CCB) meetings
    • Assist other disciplines with Agile tasks
    • Provide Agile and Document Control process training to users
    • Perform basic Agile administration tasks such as user administration and workflow development
    • Ensure that documentation complies with GMP and ISO requirements
    • Assist in development of new and revise existing Agile processes
    • Maintain hard copy quality records and administer the process
    • Organize and maintain a log for the Document Control room, and administer the document checkout process
    • Maintain the external standards reference library
    • Additional duties as defined by supervisor

    Qualifications

    • Possesses a firm understanding of configuration management principles, and the FDA and ISO requirements that pertain to them
    • Previous experience using Agile or other PLM required, Agile administration a plus
    • Understands change orders and the sign-off and release process; familiarity with drawing and BOM structures associated with electro-mechanical software-controlled systems
    • Experience with Agile workflow development a plus
    • Experience performing internal quality audits a plus
    • Five or more years’ experience working in a regulated environment
    • Associates degree required.
    • A self-motivated, self-directed and detail-oriented individual, able to work in a team and small company environment with minimal supervision.
    • Must have excellent work ethic, personal responsibility, initiative, and teamwork skills.
    • Effective verbal and written communication and interpersonal skills.
    • Proficient in the use of PC software (MS Word, Excel, etc.).

    Language and Verbal Skills
    Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, and technical procedures. Ability to write procedures, reports, and business correspondence in English. Ability to effectively present information and respond to questions from groups of managers, and internal customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.

    Math Skills
    Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

    Analytical and Reading Skills
    Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to read regulatory, technical and clinical literature and documents and extract important concepts.

    Physical Requirements
    May be required to perform lifting tasks of up to 20 pounds for short durations. Duties of this job may involve sitting for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

    Work Environment
    Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.

    Safety
    Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

     

     

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