In this role, the selected candidate will be responsible for the oversight and the conduct of audits as they relate to Good Clinical Practices (GCP), to ensure compliance with all established regulatory guidelines as well as company policies and procedures.
In this role, you will be responsible to provide leadership and participate in lot release, change control review and approval, manufacturing support, record approvals, investigations approval, lab testing changes and project support within the quality organization.
The Quality Assurance Drug Product Manager / TL will be primarily based in Sterile Product Manufacturing building (SPM) and the Sterile Product Support (SPS) building and will provide general oversight to MQA personnel and Floor QA personnel.
The QC Lab manager will be the plant point person regarding quality control and quality assurance. They will maintain plant and lab compliance with quality standards, along with continued instrumentation programs including maintenance and training.
In this role, you will manage, coordinate and direct the implementation and operation of metros engineering department quality assurance/quality control (qa/qc) program for all metrolink and other capital projects.
In this role, you will analyze legal and regulatory issues and develops and/or reviews policies and procedures. Continuously assess and improves the department performance while promoting a positive work environment which enhances employee and patient satisfaction.