In this role, you will be responsible for developing a Quality Assurance Program to ensure compliance is maintained with federal, state, county contracts, grants, accrediting bodies, labor laws and documentation retention requirements.
Review all Medicare and other episodic payers clinical records at the local level to assure appropriate documentation for reimbursement. This review includes verification of appropriate documentation, quality of care provided, visits utilization, appropriate contacts with physicians, adherence to the care plan, and evidence of communication between disciplines.
Evaluate, analyze and report on product and process quality performance to established quality goals.Monitor product quality through inspection testing and auditing. Establish statistically sound programs for sampling and process validations.
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.
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.
In this role, the selected candidate will provide quality oversight of Companion Diagnostic (CDx) and Diagnostics development programs at third party diagnostic sites and liaise with Clinical QA/Dev Ops as required in order to ensure the CDx programs meet device regulations and are suitable for use in Pfizer sponsored clinical trials.
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.