The Quality Assurance Manager is Responsible For:
1. The Quality Assurance (QA) Manager will be on the front lines of protecting the Mount Sinai Genetic Testing Laboratory from any regulatory issues by designing and performing regular checks and reviews surrounding the ever-evolving requirements and guidelines from NYS, CLEP and NGS regulatory agencies, staying a step ahead of any required changes to protect our relationships and reputation as well as safeguarding the laboratory and its staff from regulatory concerns.
2. They will be responsible for interpreting guidelines and determining how protocols should be altered to stay compliant, as well as giving concise recommendations to implement the revisions in the dynamic clinical NGS environment.
2. They will be the key responsible party for leading a multi-disciplinary group in not only keeping up with the frequently released guidelines and regulatory changes but in devising and implementing both down-steam and upstream workflows, impacting clinicians, laboratory staff, bioinformaticians, IT and institutional infrastructure without disrupting overall results or relationships with clients. The candidate must be a talented communicator, able to lead discussions, properly anticipate the effects of any changes and communicate them in advance to the appropriate parties and work with them to receive their crucial buy-in to implement modifications to workflows in the most effective manner possible without disrupting client service and turnaround times.
The Importance of the position of Quality Assurance Manager to the Organization:
1. The QA Manager is integral to the overall growth and ongoing accomplishments of the Mount Sinai Genetic Testing Lab, and as such it is necessary that the potential candidates possess an extremely specific amalgam of skills and personality traits The most distinctive aspect of the job is that it requires a candidate uniquely passionate about the distinctive and vigorous state of today’s regulatory environment.
2. They must possess a mix of robust regulatory knowledge, the ability to deliver on-time results according to strict turnaround times and work within a strict schedule in a dynamic atmosphere. They must be a compelling leader, able to guide the staff in governmental, regulatory and compliance matters to implement changes as needed after advising and coordinating the input of the Directors, Managers and Technologists. Their role will require a lot of interchange with various departments.
3. The candidate will be extremely very well-versed in the day to day operations of the laboratory and accountable for the procedures of orthogonal confirmation testing, which includes a multitude of molecular assays, including but not limited to panel NGS, MLPA, DNA extraction, PCR, Sanger sequencing, etc.as well as platform validations, bioinformatics pipelines, tool and script validations, program and database validations, updates and conformational testing.
4. They will be directly responsible for the development, implementation and monitoring of the Quality Management Plan of the MSSM Molecular NGS laboratory (wet and bioinformatics labs) including the maintaining of regulatory compliance processes and the monitoring of the molecular diagnostic laboratory by serving as the primary line of defense against any regulatory issues that could impact the laboratory and its staff in the ever changing NGS landscape.
1. The Quality Assurance Manager collects, maintains and distributes copies of all lawful, regulatory memoranda and accrediting information. They will serve as the manager of all regulatory and accreditation inspections. They must be confident in making real-time judgement calls of lab protocols and coordinate timely responses to all requests while maintaining accurate, complete, and easily understood files of all activities, interpretations, research, decisions and corresponding enactments of new procedures.
2. They will develop, implement and monitor the MSSM Lab Quality Management system and implement changes to enhance the overall Quality Process of the wet and dry labs. They will serve as author, maintainer and reviewer of the Standard Operating Procedures and Policies to ensure compliance, while overseeing the QMS scientist, coordinator and other personnel.
3. Performs and summarizes lab audits as defined by the Laboratory Quality Plan. Monitors and ensures timely implementation of corrective action plans. Generates and reports required quality metrics and data for management review to meet regulatory requirements. Regulates and records internal proficiency testing program with internal samples. Maintains and tracks Incident Analysis Forms.
4. Maintains Quality Standards by providing supervision, including work direction, work assignments and answering job-related questions. Lead the development and implementation of a comprehensive Staff Training and Competency Program. Initiates training and educational files for team members and maintains staff competency documentation.
5. Demonstrates strong expertise in the application of the Corrective and Preventive Action (CAPA) system to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.
6. Ensures proficiency testing samples are processed and submitted to appropriate regulatory agencies.
7. Manage employee training files by managing a training matrix and reviewing employee credentials on an ongoing basis.