Technical Specifications Specialist
at Ronin Staffing

Date Posted: 9/26/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title
: Technical Specifications Specialist 
Pay: Flexible
Location: Thousand Oaks, CA 91320
Duration: 1 year contract + possible extension

Job Details:

  • Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
  • Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers).
  • Interface cross-functionally within Amgen (with Process Development, Quality, Supply Chain and other GMP functions) and externally with Amgen raw material suppliers.
  • Draft specifications based on raw material attributes, where they are used in the Amgen process and how they should be controlled.
  • Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks.
  • Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.
  • Skills: Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering); preference will be given to advance degree holders and/or those who have industry and project management experience.
  • Targeting PHD/Master level candidates with 6 months’ work experience or more.

Top Must Have Skill Set:

  • Background in GMP operations and manufacturing processes.
  • Strong technical background (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
  • Change Control owner (managing revisions to specifications).

Day to Day Responsibilities:

  • Gathering requirements, generating specifications and managing changes to active specs.
  • Supporting Amgen Specification Remediation effort.
  • Analyzing information to revise the specifications.
  • Owning change control records (documenting changes and specifications).
  • This person will be leading meetings with operations, quality and PD.

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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