In this role, the selected candidate will perform all technical final financial statement review in addition to performing a variety of functions including audits, tax verses book adjustments, etc for a diverse group of private clients.
In this role, the selected candidate will assist Manager in setting up, maintaining and improving the ISO/quality management system & Quality databases in both hard files and electronic archiving systems, perform Internal Audit & preparation for ISO External Audit.
The QC Manager will assist in developing vendor standards and audit protocols to assure standards are being met, and oversee the in-house laboratory procedures and department including preparing and sending of samples to third party labs.
In this role, the selected candidate will act as a compliance resource to provide guidance and assistance towards resolution of moderate to complex deviations, quality investigations, lab investigations, CAPAs and change control.
In this role, you will work in partnership with other QRA colleagues to develop the training materials and plans to implement and execute, sustain and champion training in the areas that include medical gas manufacturing, and handling medical devices.
The Sr./Director Quality Assurance Manager, External Manufacturing manages and oversees the activities of external manufacturers to ensure products meet current Good Manufacturing Practices and Good Tissue Practices, applicable medical device regulatory requirements, and corporate quality and regulatory standards through interaction with business partners.
In this role, the selected candidate will develop quality assurance plans by identifying critical control points and preventive measures; establishing metrics, monitoring procedures, corrective actions, and verification procedures.
The Quality Manager is responsible for the food safety, quality, and regulatory compliance of the manufacturing location and for driving a culture of continuous improvement in all areas of responsibility.
In this position, you will conduct batch record review of development batches of drug substance, drug product and package/labeling jobs with particular emphasis on experience with reviewing Biologics including Cell Drug Batch Records.