Stability Program Coordinator/Data Reviewer
Job Code: #564
Job Type: Direct Hire
Salary: $65,000 - $80,000
Job Location: Waukegan, IL
Job Description Job Title: Stability Program Coordinator/Data Reviewer
Salary: $65,000 - $80,000
Job Summary: Oversee the stability and reference standard programs through study design, protocol and report writing, as well as packaging samples appropriately for stability storage. Review cGMP data for technical adherence to procedures and compliance to regulatory standards and internal SOPs. Mentor staff on documentation and testing organization.
Essential Duties and Responsibilities:
• Responsible for the administration of the stability program (50%)
o Preparation and initiation of stability protocols
o Preparation of stability reports (internal and external)
o Stability sample management, monitoring and submission
o Review of analytical stability data for compliance with company policies and procedures, and cGMP regulations and ICH guidelines.
o Stability data review and evaluation
o Coordination with QC supervisor to schedule stability testing.
o Maintain stability program per ICH, IPEC and cGMP regulations.
• Responsible for the management of the reference standard program (5%)
o Initiation of reference standard qualification protocols
o Preparation of reference standard qualification reports
o Maintain reference standard program per SOP and regulatory requirements.
• Responsible for data review to include raw material / intermediate release, in-process
testing, final product release as required by QC deliverables and goals (45%).
Review and edit policy and procedure documents as necessary to meet cGMP regulations and ICH guidelines.
• Operate following company policies and procedures to meet cGMP regulations and ICH guidelines.
• Maintain documentation in an accurate, clear and concise manner in accordance to company policies and procedures.
• Maintain a clean, safe and orderly workplace, following all applicable EHS policies and procedures.
• An MS with 2+ years in a GMP analytical laboratory environment or BS with 5+ years in a GMP analytical laboratory environment.
• Ability to make independent decisions with regards to data compliance and adherence to cGMP requirements and internal SOPs.
• Ability to critically self-review and review work of others for accuracy and quality against established procedures
• Organized and able to prioritize and perform duties in a timely manner
• Detail oriented
• Good written and verbal communications skills
• Working knowledge of cGMP regulations
• Working knowledge of ICH stability requirements.
• Ability to train others