In this role, the selected candidate will be responsible for maintaining the technical accounting standards, policies and procedures for the firm's audit and assurance practice by keeping up to date and implementing the pronouncements of the FASB, PCAOB and SEC.
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.
The Senior Manager Pharmacovigilance Quality / PV QA is responsible for performing domestic and international audits to ensure compliance with the FDA and global Drug Safety and Pharmacovigilance / PV regulations and guidelines, site SOPs, protocols, and industry standards.
The QC Manager plans, directs and coordinates all on-site Quality Control (QC) activities to ensure compliance with applicable company, owner, and government regulations and requirements. The QC Manager is responsible for implementing the QC Plan in its entirety and making appropriate and necessary changes to the plan throughout the project duration.
In this role, the selected candidate will manage cGMP release and stability testing at Momenta and contract testing laboratories; manage the implementation, qualification, validation and transfer of analytical methods.
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 be responsible for administration of Compounding Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time.
In this role, the selected candidate will be responsible for the safe and effective use of materials and equipment and ensure compliance with the defined policies and procedures including regulatory, GMP and HACCP.