What are the responsibilities and job description for the Quality Systems Specialist position at Katalyst CRO?
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.