Quality Assurance Manager
Iselin, NJ, United States
As the Quality Assurance Manager, you will be responsible for clinical quality of laboratory operations. Working closely with the Director, Quality Assurance & Regulatory Affairs, you will provide quality oversight for development and commercial services.
Location: Metropark, NJ, this is a hybrid position requiring 3 days onsite.
What you'll do:
Guides the implementation, maintenance, and monitoring of processes and procedures to ensure compliance with relevant guidance and requirements.
Handles document and record control.
Leads the training programs.
Supports the tracking, monitoring, and presentation of operational and quality metrics
Initiates or supports as needed quality improvements initiatives to improve performance and/or mitigate quality or compliance risks.
Provides guidance in assessing non-compliance events and supports the team effort to define corrective and preventive actions as well as supervising their effectiveness.
Supports the internal audit program and supplier qualification program
Assures executive staff is advised of any issues that may adversely impact the Quality System.
Supports independent monitoring of study conduct to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with internal procedures and follow regulations.
Liaise with external entities such as customers, auditors, and/or regulatory agencies on matters relating to the Quality Management System at the discretion of Quality Assurance Director.
What you'll bring:
5+ years of experience in the Healthcare industry (CAP/CLIA/ISO environment) with 2 years of GCP/GCLP-related Quality Assurance experience.
Bachelors in science, biological science, computational biology, or biotechnology.
CQA auditor certification is a plus
Strong organizational and leadership skills to communicate to multi-disciplinary project teams.
Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.
The ability to think strategically and maintain an attention to detail.
Capable of working independently with little supervision and interacting with staff in a fast-paced sometimes pressure filled environment.
Excellent written and verbal communication skills coupled with strong negotiation and decision-making skills.
Strong comprehension while applying critical thinking skills to evaluate requirements.
Ability to present data and defend approaches to inspectors.
#J-18808-Ljbffr