Quality Systems Specialist

Responsibilities:

• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations.
• Navigate complex change review discussions, facilitating decisions regarding approach and follow-up actions, and document these evaluations.
• Support management and monitoring of change records for adherence to organizational or departmental metric targets and maintain associated tracking tools and databases.
• Assist in the management review process by developing and generating quality system metrics and trends, escalating issues as necessary.
• Contribute to the maintenance and improvement of quality systems processes as needed.
• Collaborate directly with operating entities and internal clients to ensure follow-up on change tasks.

• 6+ years of relevant experience in a GMP environment for biologics manufacturing with a BS or BA, including mandatory change control experience.
• 4+ years of relevant experience with a MS degree.
• Change control experience from a regulated industry such as medical device, pharma, nutraceuticals, or vitamins, with FDA-related knowledge.
• Strong communication skills, good time management skills, and attention to detail.
• Knowledge of good technical writing.