Sr. Specialist- QC Compliance
6 month contract
A top pharmaceutical and biotech company is looking for an Sr Specialist for QC Compliance with demonstrated experience working in a cGMP pharmaceutical environment. This is a 6 month contract opportunity that is on site in Norwood, MA.
- Oversee and lead the QC area inspection readiness program to provide compliance guidance for the entire QC department.
- Provide compliant solutions and suggestions through identifying QC areas for continuous improvement.
- Revise SOP's and documentation to ensure regulatory requirements/compliance is being met
- Masters and 2-5 yrs experience OR a Bachelors and 5-8yrs experience with relevant experience in a pharmaceutical cGMP environment
- Technical writing skills and experience w/ deviations, investigations, and cGMP/SOP's
- Knowledge of relevant FDA, EU, ICH guidelines