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Senior Site Quality Manager

Department: Operations
Office or Remote: PRL NYC
Location: Long Island City, NY
Business Unit: Pandemic Response Lab (PRL)

 

Location: Long Island City, NY

About Us
Opentrons Labworks, Inc., is a disruptive life science company leveraging its integrated lab platform to supercharge the pace of innovation in research and healthcare. Through our business unit, Opentrons Robotics, thousands of institutions are automating R&D operations with flexible, easy-to-use lab robots. Health systems across the US rely on our Pandemic Response Lab (PRL) to deliver high-throughput and affordable molecular diagnostic testing. And through recent acquisitions Neochromosome and Zenith AI, biopharma can benefit from our world-class genome-scale cell engineering solutions. 

We provide excellent benefits, competitive compensation, equity packages, and opportunities for growth. If you are looking for your next exciting opportunity, come join us!

Benefits

  • Comprehensive Medical, Dental and Vision insurance for employees and their families

  • Paid Vacation, Parental and Sick Leave

  • Generous Stock options

  • 401k with 4% company match

  • Long-term and short-term Life & Disability insurance

  • And much more!

About The Role

The Sr. Site Quality Manager is responsible for the Quality programs, systems, processes and procedures and that the performance and quality of services conform to established regulatory and accreditation requirements within the assigned laboratory or geographic region. Leads the internal audit program and resolution of audit and inspection findings; manages the internal and external proficiency testing program, manages the nonconforming event program and facilities continuous improvement. Oversees compliance with CLIA, CAP, ISO 15189 and other regulatory and accreditation requirements.

Responsibilities

  • Provide oversight of all aspects of the laboratory’s quality management system to ensure conformance to requirements described in the Opentrons, PRL Quality Management System and drive/support Corporate QMS initiatives and continuous improvement activities.
  • Partners with laboratory leadership to develop quality goals and objectives.
  • Ensures all laboratories within the assigned area(s) maintain current federal, state and local licensure and accreditations, as applicable.
  • Provides guidance for laboratories in implementing policies with respect to regulatory and accreditation requirements.
  • Audits laboratories to identify quality issues, nonconformities and opportunities for improvement.
  • Formulates responses to accreditation and regulatory citations, nonconforming events and complaints.
  • Performs root cause investigations and monitor outcomes, corrective action and effectiveness checks.
  • Facilitates process improvement projects activities.
  • Collects summary data for management reports regarding quality indicators, internal and external audit outcomes, and complaints.
  • Hosts Quality Management Review Meetings and prepares minutes
  • Leads development and implementation of policy and procedure creation for Quality Management Systems
  • Provides and ensures training for PRL clinical laboratory quality policies and procedures.
  • Evaluates and signs off on licensure applications and ensures licenses are renewed within the prescribed time frames.
  • Prepares site for internal and external inspections and directly interfaces with auditors/inspectors, (CAP, NY State and States applications and inspections).
  • Performs Quality Safety (QS) training for new hires Maintains and coordinates communications between laboratories in the assigned area(s), providing assistance where indicated on quality related issues.

Qualifications

  • Bachelor’s degree in a physical, chemical, biological, or clinical laboratory science and 5+ years in high complexity testing in CLIA/CAP environment;
  • Solid knowledge of CAP, CLIA, New York State's regulations, ISO 15189, including successfully having completed multiple CAP inspections.
  • A minimum of 5 yrs experience of hosting audits and direct interaction with CAP/NYSDOH and/or other regulatory agencies.
  • Experience writing, evaluating and closing investigations, CAPAs and change control records.
  • Willingness to think outside of the box and adapt best practices to this small, but growing environment.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
  • Knowledge of testing equipment, statistical methods, validation methods, problem-solving, and control plans.
  • Has a proven track record of delivering results and is action-oriented.
  • Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.


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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