Specialist Quality Complaints
at Ronin Staffing

Date Posted: 11/4/2019

Job Description

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

Description

  • Onsite M-F normal core hours
  • Ideal candidate- BS in science, PM skills, Complaints experience within medical devices, detailed orientated. Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment
  • Accountable to conduct complex complaint investigations, determine corrective actions with their effectiveness and determine the steps necessary to ensure the proper level of control for product in distribution.

Key Responsibilities

  • Ensures quality of complaint records
  • Applies analytical skills to evaluate complex situations using multiple sources of information
  • Execution of regulatory and SOP requirements
  • Anticipates and prevents potential issues with regulators
  • Provides guidance and technical advice
  • Evaluates subject matter expert assessments
  • Escalates potential Quality issues to Management

Authority

  • Owns complex quality record content
  • Determines situations which require escalation to management
  • Determines when a complaint dictates further investigation
  • Works under minimal direction
  • Proposes revisions to SOPs in area of responsibility

Basic Qualifications:

  • Doctorate degree OR
  • Master’s degree & 2 years of directly related experience OR
  • Bachelor’s degree & 4 years of directly related experience OR
  • Associate’s degree & 10 years of directly related experience OR
  • High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • Ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to travel +/- 10% of time to domestic and international Amgen sites

Top Must Have Skill Set:

  • Strong project management skills
  • Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment

Day to Day Responsibilities:

  • Supporting the product complaint system at Amgen through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. - Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
  • Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations. Follow-up on corrective actions derived from investigations through completion.
  • Conducting and documenting the investigation.
  • May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
  • 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.

To learn more about our team of professionals, join our Talent Network today!

What is a Talent Network?

Talent Networks enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected with you.

Why Join?

  • Receive alerts with new job opportunities that match your interests
  • Share job opportunities through Social Media or email