Sr. Associate Quality Complaints

Thousand Oaks, California
Industry: Business Analyst / Project Manager
Job Number: JN -112019-50259

Responsibilities:

  • Initiate and coordinate product complaints. Interface with call centers, various sites and business partners to ensure call intake process compliance. Complete and approve product complaints requiring no further investigation. Reconcile reported product complaints to ensure entry in product complaint system.


Requirements:

  • Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience.
  • Typically, 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation and documentation according to company guidelines.
  • Be self-motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement instructions.
  • Strong word processing, database and spreadsheet application skills. Strong organizational skills with the ability to manage multiple projects or assignments.
  • Key Responsibilities:
  • Ensures quality of complaint records
  • Applies analytical skills to evaluate complex situations using multiple sources of information
  • Executes SOP requirements
  • Develops solutions to technical problems of moderate complexity
  • Screens, evaluates, reports and resolves record integrity issues


Basic Qualifications:

  • Master’s Degree OR
  • Bachelor’s Degree & 2 years of directly related experience OR
  • Associate’s Degree & 6 years of directly related experience OR
  • High School Diploma / GED & 8 years of directly related experience


Preferred Qualifications:

  • Quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)


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