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Technical Specifications Specialist - REMOTE (JP9244)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Technical Specifications Specialist - REMOTE (JP9244)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Raw Material Specificaitons
Duration: 12+ months (with likely extensions)
Notes: 100% REMOTE
Posting Date:  10/08/2021

3 Key Consulting is hiring a Technical Specifications Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
  • 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 client (with Process Development, Quality, Supply Chain and other GMP functions).
  • Draft specifications based on raw material attributes, where they are used in the client 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.

Why is the Position Open?
Planned Project.

Top Must-Have Skill Sets:
  • Analytical procedure knowledge.
  • Technical writing.
  • Communication.
  • Change control records is a plus

Day to Day Responsibilities:
To create or revise raw material specifications, facilitate technical meeting for raw material specification development, own change controls related to raw material specifications.

Basic Qualifications:
  • Bachelors degree in science related field with some work experience Masters or PHD in science related field
  • 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.

Employee Value Proposition:
This role is very versatile and will require you to communicate to different levels of the organization.

Red Flags:
previously applied for this position.

Interview process:
Phone screening followed by in-person interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  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 www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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