QA Manager

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Job description

About PRL

During the height of the coronavirus pandemic, a group of leading experts came together to launch the Pandemic Response Lab (PRL) which was announced by NYCs Mayor De Blasio in August 2020. As New York City reopens, PRL is expanding its panel of non-COVID diagnostic tools with the aim of making diagnostic testing easier, faster and more accurate for a broad spectrum of health applications. Based in Innolabs in Long Island City/Queens, PRL is a state-of-the-art high complexity lab dedicated to advance the field of molecular diagnostics.

About the Role

The Laboratory Quality Control/Quality Assurance Manager will work with the director/lab manager and be responsible for creating and maintaining a Quality plan which will be compliant with CLSI, CAP and NYSDOH standards. Makes sure that quality standards are being met, from all departments. The QA Manager provides technical expertise to the laboratory and as needed, serves as the liaison to external governing entities. The Laboratory Quality Control and Quality Assurance Manager ensures that the laboratory and the laboratory staff is in compliance with all laws and regulations that are required by CLIA, CAP, OSHA, NYSDOH, DNV and any other applicable legislative organizations.

The Laboratory Quality Control and Quality Assurance Manager is expected to hold regular periodic meetings with the Laboratorys management team to assure the lab is always inspection ready at any moment.

Responsibilities:

* Be a proactive leader and identify opportunities and propose improvements, efficiencies and operational modification as it relates to the laboratory

* Responsible for scientific oversight of the laboratory including writing and review of all SOP's.

* Identify and understand regulatory requirements to ensure the laboratory is in compliance with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP, NYSDOH, DNV and other requirements and regulations for states in which the lab is licensed

* Collaborates with the Medical Director of the Laboratory to Crate, optimize and enforce the Quality Plan as it is written.

* Maintains a state of readiness for inspections at all times, through regular periodic meetings with all department managers and supervisors, self inspection check lists and Proactive observation.

* Supports, implements, and ensures compliance with all departmental and company policies and procedures including but not limited to Quality, Compliance with all regulatory entities and Safety

* Is expected to work with all Managers, Supervisors and Employees on meeting the standards in the Quality Plan

* Prioritizes responsibilities, anticipates problems and provides timely and appropriate solutions.

* Ability to liaison with other operational areas.

* Responsible for validating and implementing new methods and technologies

Technical Responsibilities

* Verify the test procedures performed and establish the laboratorys test performance characteristics, including precision and accuracy of each test and test system

* Ensure that the quality management program is maintained by following parameters for acceptable performance for the pre-analytical, analytical and post-analytical testing processes

* Resolve all technical problems with the aid of the technical staff and ensures that remedial action is taken whenever a test deviates from the laboratorys performance standards

* Ensure that all patient results are not reported until corrective actions have been taken and the systems are functioning properly

* Identify training needs and ensures all training is performed as required

Requirements

* BSMT or BS Degree in one of the life sciences (Biology, Chemistry, etc.), Clinical Lab Science, or in Medical Technology
* State Licensure (CA state licensing)
* 6 years laboratory experience as a Medical Technologist in a CLIA accredited clinical laboratory
* ASCP certification or equivalent is desired
* Proven experience in the areas of laboratory leadership, Laboratory Information's System (LIS) requirements and workflow needs and technical capabilities
* Experience working with Quality Management including strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA and other related legislative and/or state health departments and organizations
* Excellent professional communication skills, including verbal, written, and presentation, with a knowledge of Microsoft Office
* Excellent collaboration skills, with the ability to positively influence others Strong leadership skills; able to support and demonstrate company mission, and perform as a team member and leader
* Strong strategic, and proactive thinking skills; able to make and support decisions
* Strong scientific and analytical skills
* Computer proficient with multiple software programs, including MS Office Suite, and Laboratory Management Systems

About Opentrons

Currently, over 90% of biologists in the world run experiments with manual pipettes, moving tiny amounts of liquid from vial to vial by hand. By making robotics affordable and open, we can build a common platform to help all life-scientists easily execute and share their experiments.

Opentrons robotics are in use in over 40 countries around the world and have been adopted by top-tier institutions like Stanford, Harvard, Merck, and Roche. Opentrons is VC-backed with investors including Khosla Ventures, Lerer Hippeau Ventures, and Y Combinator.

About Neochromosome

Neochromosome (part of Opentrons) is a biotech startup whose disruptive chromosome synthesis and engineering technologies are changing the world of synthetic biology. Rather than piecemeal editing of an existing genome, Neo delivers entire chromosomes designed de novo to be modular and orthogonal to the host cell. Neos work has revolutionized the Design - Build - Deliver paradigm for biological engineering with a focus on higher eukaryotic cells for expression of commercially valuable biological pathways.

Opentrons is an equal opportunity employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

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