Technical Specifications Specialist

OQSIE

Thousand Oaks, CA

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JOB DETAILS

SKILLS

Analytical Chemistry, Biochemistry, Biology, Candidate Sourcing, Change Control, Chemical Processes, Cross-Functional, GMP (Good Manufacturing Practices), Manufacturing, Manufacturing/Industrial Processes, Meeting Minutes, Process Development, Requirements Management, Small Molecules, Supply Chain

LOCATION

Thousand Oaks, CA

POSTED

30+ days ago

****Please do not submit past *** hr bill rate****

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

Targeting candidates with 2 years work experience or more.

About the Company

OQSIE

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