The QA Specialist I - Operations will provide support to the overall Quality Assurance program at the site. This individual will ensure that plant operations are within cGMP, local procedures, and corporate policies.
The Quality Specialist IV has responsibility for GMP activities related to materials, production, product release, labeling, change control and post market monitoring activities for assigned RAI operating company. This individual will serve as the main quality contact between Contract Manufacturing Organizations (CMOs) and S&RA Quality Assurance group.
In this role, you will play an important role in building the capabilities and capacity of UNC HCS entities and employees to improve the value streams directly related to patient care and the other supporting value streams that enable patient care and health care operations.
In this role, you will work with members of MV, R&D, QC, QA and other groups (Manufacturing, Validation, etc.) as necessary to generate validation and stability protocols for raw materials, process intermediates, and final product.
In this role, you will be responsible to assist with the development and maintenance of the annual internal audit plan for quality system audits and assures audits are carried out according to the plan.
In this role, you will maintain relationships with stakeholders and customer where disruption is caused by essential maintenance and construction work, ensuring that complaints service and applications for mitigating circumstances are co-ordinated.