Overview
Remote
On Site
Hybrid
$38 - $40 hr
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
DOCUMENTATION
REGULATORY
GMP
RAW MATERIAL
SPECIFICATION
PROJECT MANAGEMENT
ERP
SAP
Job Details
Payrate: $38.00 - $40.00/hr.
Summary:
The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing to regulatory filings and compliance efforts. Candidates with laboratory experience are often successful in this role, though no hands-on lab work is expected This is a high-impact documentation role critical to raw material support across global sites.
Responsibilities:
Qualifications:
Top Must Have Skill Sets:
Pay Transparency: The typical base pay for this role across the U.S. is: $38.00 - $40.00/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 ().
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 to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-21227
Summary:
The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing to regulatory filings and compliance efforts. Candidates with laboratory experience are often successful in this role, though no hands-on lab work is expected This is a high-impact documentation role critical to raw material support across global sites.
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 (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.
- 50/50 role split between Project Management and Specifications Management
- Perform specification management duties in support of year-over-year time reduction goals
- Report, analyze, and maintain departmental KPIs for performance tracking
- Support and potentially lead initiatives that improve departmental operations
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.
- A Bachelor s or Master s degree is preferred, and strong communication skills are essential.
Top Must Have Skill Sets:
- Strong project management skills
- Effective written and verbal communication
- Experience developing raw material specifications (non-lab based)
- Knowledge of GMP-controlled document systems
- Proficiency with ERP platforms, particularly SAP
Pay Transparency: The typical base pay for this role across the U.S. is: $38.00 - $40.00/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 ().
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 to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-21227
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.