Senior Associate Quality Complaints – Biopharma (JP4427)

Location: Thousand Oaks, Ca
Date Posted: 06-26-2018
Job Title: Senior Associate Quality Complaints – Biopharma (JP4427)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
Business Unit: Quality Operations
 
3Key Consulting Inc. is looking for a Senior Associate Quality Complaints with 2 – 5 years’ experience working in quality Assurance or manufacturing within a GMP pharmaceutical or medical device industry, basic statistical/mathematical skills and project management experience for a global, CA-based, bio-pharmaceutical company.
 
Job Summary:
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:
  • 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. 
    Preferred: IRPC experience (proprietary system to Amgen)          
 
Top must have 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.
 
Day-to-day responsibilities:
Process and close complaints in a timely manner. Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.
 
Why this position is open: Previously outsourced work, bringing this group internal.
 
Employee value proposition: This is a new space to Amgen building this org from the ground up. May interface with high level employees. This role has the potential to move into a full time position.
 
Interview process: Panel phone interview to hire.
 
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We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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