Overview
Remote
On Site
Hybrid
$38.6 - $41.74 hr
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
RAW MATERIAL SPECIFICATION
RAW MATERIALS SPECIFICATION
RAW MATERIAL SPECIFICATIONS
RAW MATERIALS SPECIFICATIONS
GMP
SAP
ERP
PROJECT
DOCUMENT
CONTROL
CONTROLLED
Job Details
Payrate: $38.60 - $41.74/hr.
Responsibilities:
Qualifications:
Desired Skills:
Pay Transparency: The typical base pay for this role across the U.S. is: $38.60 - $41.74 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Responsibilities:
- 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 the company (with Process Development, Quality, Supply Chain and other GMP functions) and externally with raw material suppliers.
- 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.
- Perform specification management duties ensuring support of YOY throughout time reduction goal
- Report and maintain departmental KPI's
- Support- and potentially lead-departmental operational improvement projects
Qualifications:
- 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.
Desired Skills:
- Project management experience
- Experience in GMP controlled documents management
- Knowledge of ERP Systems (SAP)
Pay Transparency: The typical base pay for this role across the U.S. is: $38.60 - $41.74 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.