Technical Specialist Raw Materials
Spectraforce
Thousand Oaks, California
2 hours ago
Job Description
Position Title: Technical Specialist Raw Materials
Work Location: Remote
Assignment Duration: 12 Month
Work Schedule: Exact Shift - remote role, 40hrs a week
Position Summary:
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).
Background & Context: Interface cross-functionally within The Organization (with Process Development, Quality, Supply Chain and other GMP functions) and externally with raw material suppliers.
Key Responsibilities:
• 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.
Qualification & Experience:
• 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.
Must Haves:
1. Draft specifications based on raw material attributes
2. Facilitate specification development meetings and generate meeting minutes/action items
3. Change owner and initiator
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.
Work Location: Remote
Assignment Duration: 12 Month
Work Schedule: Exact Shift - remote role, 40hrs a week
Position Summary:
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).
Background & Context: Interface cross-functionally within The Organization (with Process Development, Quality, Supply Chain and other GMP functions) and externally with raw material suppliers.
Key Responsibilities:
• 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.
Qualification & Experience:
• 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.
Must Haves:
1. Draft specifications based on raw material attributes
2. Facilitate specification development meetings and generate meeting minutes/action items
3. Change owner and initiator
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.