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Senior Associate Quality Complaints - Combination Drug Device (JP4902)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title:  Senior Associate Quality Complaints - Combination Drug Device (JP4644)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Complaint Investigators
Duration: 12 months with likely extension
3Key Consulting Inc. is recruiting for a Senior Associate Quality Complaints with 3 - 5 years’ experience in managing complaints related to biologics, medical devices and solid dose products within a cGMP/GxP environment for a global, CA-based, bio-pharmaceutical company.
Job Description:
Candidate will perform the following functions:
  • Initiate and coordinate product complaints.
  • Interface with call centers, various Amgen 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 database.
  • Perform return sample coordination and visual assessment.
  • Archive documents related to product complaints.
Top Must-Have Skill Sets:
  • General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
  • Experience in managing complaint related to biologics, medical devices and solid dose products.
  • Candidate must have proven computer literacy as well as independently understanding, following and implementing instructions.
  • Candidate must be well-organized, possess excellent oral and written communication skills, and have the ability to function in a fast-paced environment.
  • Must be able to work independently or as a team player and collaborate with outside resources.
Day to Day 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 to assure regulatory compliance across all product lines.
  • Other duties as assigned.
Basic Qualifications:
  • 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.
Why This Position Is Open:
Supplement additional workload on team.
Employee Value Proposition:
Opportunity to understand the quality systems of complaints and how it impacts drug product.
Red Flags:
  • Lack of GMP/GXP.
  • Lack of Quality experience
Interview process:
Phone, then in-person if needed.
We invite qualified candidates to send your resume to  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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