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Sr Associate Quality Complaints
Ref No.: 18-06668
Location: Thousand Oaks, California
Position Type:Prof (T)
Start Date / End Date: 06/04/2018 to 12/31/2019
Our client, a leading fortune company is looking for a Sr. Associate Quality Complaints. This is for an initial duration of 18 months and is located in Thousand Oaks, CA
 
Top Skill Sets:
  • 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.
 
Description:
  • This position will be responsible for triaging and investigating complaints integral to the design, manufacture, delivery and service of our products.
  • Interact with and communicate with internal and external customers while meeting regulatory compliance and its required documentation. Investigate complaint records, process and close complaints while following company procedure.

Responsibilities
  • Interact and communicate with internal and external customers for reporting of complaints and adverse events (this may include intake and/or follow –up requests for information.)
  • Ensure that all complaints requiring customer responses are properly addressed as assigned.
  • Understands the complaint handling process from initiation to closure.
  • Process and close complaints in a timely manner.
  • Maintain current knowledge of the Regulatory regulations
  • Serves as an internal review in order to assure regulatory compliance across all product lines.
  • Other duties as assigned.
 
Other responsibilities may include:
  • Performing data analysis and trending of complaint information to proactively detect signals and take appropriate action.
 
Requirements:
  • 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.
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.