Quality Assurance Specialist II
3 days ago
* Assist in preparing QC metrics on a monthly basis
* Ensure that all stability testing is conducted within the specified window
* Work directly with contract laboratories to coordinate and monitor testing and release schedules
* Work directly with customers to update and confirm schedules and deadlines
* Attend daily briefings and provide updates as needed
* Maintain and execute a minimum of 8 stability protocols
* Provide technical suggestions to customers based on industry guidelines
Requirements
* Bachelor's degree in chemistry, biochemistry, biology, biotechnology, microbiology or similar education
* Minimum of 2 years' experience in a coordinator/management position and 1 year in a GxP setting
* Master's degree and minimum of 1 year experience between coordinator/management position and 1 year in a GxP setting preferred
* PMP certificate preferred
Skills
* Extensive knowledge of stability testing protocols, methodologies, and regulatory requirements
* Understanding of ICH guidelines for stability testing
* Good organizational, written and oral communication skills
* Ability to work independently or as part of a team
* Experience with electronic planning tools and Laboratory Information Management Systems (LIMS) preferred
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