Quality Complaints Senior Associate
at Ronin Staffing

Date Posted: 11/20/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title:
Quality Complaints Senior Associate 
Pay: DOE
Location: Thousand Oaks, CA 91320
Length: 1 year contract + possible extension

Responsibilities:

  • 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.

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.

Top Must Have Skill Set:

  • 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. In addition, 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 in order to assure regulatory compliance across all product lines
  • Other duties as assigned

Job Snapshot

About Us

Founded in 1999 as a woman- and minority-owned IT staffing organization, Ronin Staffing has grown into a full-service staffing search firm that recruits and places qualified and quality candidates with expertise in a wide range of areas, including Engineering, Aerospace, Administration, Accounting/Financing, to name a few. We offer contract-only, contract-to-hire or direct-hire services to our clients and our contractors alike.

Our team of experienced, dynamic and tenacious recruiting specialists will provide you with the personal assistance you need to keep your career moving onward and upward. Whether you are looking for hourly, mid-management or executive level positions, you can be confident in our recruiters’ ability to match you with just the right assignments with just the right companies to suit your needs. Many members of our staff have backgrounds in the industries for which they now recruit, and Ronin has become one of the leaders in providing professionals to Fortune 100, 500, and 1000 companies.

We are proud to offer you a full line of services to help you to meet your career objectives, including resume assistance, human resources consulting, and expert guidance on professional interviewing techniques. We also offer direct deposit and a competitive benefits package.

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