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.
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.
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.
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.
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. 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.