Offers “Roche”

Expires soon Roche

Affiliate Complaint Management Sample Manager

  • San Francisco (City and County of San Francisco)
  • Design / Civil engineering / Industrial engineering

Job description

  Job facts

This role provides quality oversight on behalf of the US Affiliate Complaint Management (ACM) for the product complaint intake process at the US Affiliate. Various complaint activities related to the product complaint process include record intake, complaint sample management, issue resolution, reconciliation, and record closure. Additionally, collaboration with fellow ACM colleagues around call center oversight is needed to provide business continuity and redundancy.

Job Responsibilities

·  Management and ownership of the sample management process for US ACM, including:
·  Receipt, handling,andevaluationof complaint samples,which can includecontrolledsubstances, andpotential biohazardous and cytotoxic materials
·  Ensuring complaint sample inventory, chain of custody, destruction, and reconciliation are performed and documented in accordance with regulations and local procedures
·  Product complaint closure oversight including final review of US complaint investigations for accuracy and completeness according to established procedures
·  Draft complaint communication to complainants upon receipt and at close of investigation.
·  Perform and document various reconciliation efforts (Product Complaints (PCs) to Adverse Events (AEs), AEs to PCs, etc)
·  Representation of US ACM processes during Health Authority inspections
·  Problem resolution and decision-making for daily issues
·  Implementation of LPS (Lean Production System) for ACM and sample management continuous improvement
·  Additional product complaint activities in support of the US ACM

Job Requirements

·  BA/BS in Life Science or equivalent experience preferred
·  Minimum of 2-4 years in the pharmaceutical/biotechnology industry
·  Lab skills and handling
·  Ability to interpret and apply Quality standards
·  Problem solving and continuous improvement
·  Strong communication skills, both verbal and written
·  Good judgment and decision-making skills
·  Ability to work independently with general instructions as a part of a geographically distributed team
·  Collaborative with ability to work in teams locally and remotely.

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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