In this role, the selected candidate will be maintaining the technical accounting standards, policies and procedures for the firms audit and assurance practice by keeping up to date and implementing the pronouncements of the FASB, PCAOB and SEC.
In this role, you will be responsible to oversees the scheduling, documentation, and follow up on audits of domestic and foreign suppliers of active pharmaceutical ingredients, excipient materials, packaging components contract service providers including testing laboratories, engineering, technical or regulatory service providers as well as contract manufacturing service providers that are being used or considered for use as processors or packagers of drug product.
Maintains master internal and external audit schedules for the par audit group.
The Quality Assurance Manager is charged with developing and maintaining a system to assure that all products manufactured by the organization comply with Prerequisite and Food Safety Programs both external and internal requirements, legal compliance and customer expectations.
In this role, the selected candidate will be responsible for completing periodic reviews for all QC laboratory systems including Risk Assessments and implementation of all gaps identified through periodic reviews.
In this role, you will ensure good health and management of the system through the monitoring of process performance, reporting metrics, training, and leading continuous improvement initiatives for process optimization.
In this role, the selected candidate will be responsible for management of proficiency testing enrollment, performing internal departmental audits, assisting with external inspection/accreditation surveys, occurrence reporting evaluation, and development and implementation of performance improvement initiatives.
In this role, the selected candidate will identify and prioritize opportunities to significantly impact operational effectiveness through process improvement and work with stakeholders to deliver these improvements.
In this role, the selected candidate will
design quality assurance programs and systems for product and/or process development, manufacturing and testing to ensure product quality and compliance with regulatory requirements.
In this role, you will manage QC Analytical Science routine testing functions, to encompass DS and DP release and stability testing for Phase I and Phase II drug programs as well providing analytical support to the Process Sciences (PS) department to complete process validation analytical testing for late stage candidates.