Sr Specialist QA
at Ronin Staffing

Date Posted: 8/4/2020

Job Description

Title: Sr Specialist QA 
Pay: up to $35.50/hr
Location: Thousand Oaks, CA 91320
Duration: 8 month contract with possible extension 

Job Description:

Amgen is seeking a Specialist to support the Engineering Compliance and Risk organization. The role will be responsible for supporting all aspects of compliance throughout the inspection lifecycle and maintaining inspection readiness within the Engineering organization.

Top Must Have Skill Set:

  • Knowledge of GMP/ GLP regulatory requirements and/or Quality Management processes
  • Experience having direct interactions with regulatory agencies
  • Audit management experience (internal and/or regulatory)
  • Ability to effectively communicate with varied client base, including all Engineering teams, auditors and management.
  • Experience leading and managing improvement initiatives
  • Basic understanding of Engineering functions such as equipment maintenance, facilities maintenance and capital construction projects.

Day to Day Responsibilities:

The scope of compliance within Engineering includes GxP (GMP/ GLP/ GDP) and Environmental Health, Safety (EHS) audits and inspections. Duties include:

  • Lead Engineering teams to identify key compliance issues, formulate a strategy to address these issues, and communicate strategy to senior management
  • Provide guidance on inspection preparation activities, such as compliance assessment plans, playbooks and overview presentations
  • Serve as the point of contact between Engineering functions and inspecting/auditing teams
  • Assist Engineering functions to develop annual inspection readiness strategies and manage planned inspection readiness activities
  • Oversight for deviation triage and management
  • Educate staff on compliance process and requirements
  • Lead Engineering teams in the formulation of audit responses to ensure observations are addressed in a strategic and systematic manner and track commitments to closure
  • Lead cross functional forums to maintain a compliant network, resolve issues, and share best practices

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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