Laboratory Quality Manager

Genuity Science is a global leader in high quality contract genomics. To build on our mission to improve lives through genomics, we are investing in our global laboratory footprint and are seeking a Laboratory Quality Manager to join our Woburn, MA clinical genomics facility. This individual will be responsible for establishing, implementing, and maintaining the laboratory quality management system.

Duties and Responsibilities

  • Maintain QMn-GEN-001 Quality Manual.
  • Approve validation protocols.
  • Maintain and administer Q-Pulse System.
  • Create and maintain a functional document control system controlling all of Genuity Science’s documents (internally generated and from external sources).
  • Coordinate awareness of laboratory needs and requirements of users and set the quality objectives.
  • Provide technical status reports to laboratory management at the appropriate meetings on the functioning and effectiveness of the laboratory’s quality management system.
  • Ensure that documents are reviewed on schedule and meet Genuity Science’s quality and safety standards.
  • Maintain laboratory asset register.
  • Ensure that laboratory quality system documents and forms are retained for reference and inspection and are readily available.
  • Monitor whether Genuity Science’s internal quality controls are routinely performed in conjunction with senior laboratory staff.
  • Review laboratory technical documents to ensure that they are not altered without authorization in conjunction with the senior laboratory staff and management.
  • Ensure that internal audits of system and process performance are scheduled and performed so that each audit is closed within a desirable time frame.
  • Confirm that external quality assessments are performed on all of Genuity Science’s tests and addressed at the relevant meetings.
  • Scheduling and management of pharma and other external commercial inspections.
  • Follow up on Genuity Science’s external inspections and verify the completion of corrective action as required by the reports of the inspectors. Ensuring that laboratory equipment maintenance and calibration activities are recorded on Q-Pulse System.
  • Creating and maintaining a validation protocol for each item of laboratory equipment and laboratory assays.
  • Continuously improve laboratory quality and identifying areas and particular projects where there is the potential for improvement of quality, investigating results, service complaints, incidents, and ensure that effective immediate and follow up actions are taken.
  • Track and trend non-conformances to ensure any trends are identified over time.
  • Record and manage non-conformances and associated actions including actions required as result of tracking and trending reports.
  • Monitor non-conformance reports raised and provision of assistance to laboratory staff to ensure appropriate remedial action, root cause and corrective actions are documented and completed.
  • Provide information periodically for management quality review.
  • Ensure that Genuity Science’s Woburn laboratory operates within a quality management system that meets the requirements of the College of American Pathology (CAP), Clinical Laboratory Improvement Amendments (CLIA) regulations, and ISO15189 accreditation standards.
  • Partake in Woburn laboratory meetings, decision-making and policy implementation as needed.
  • Adhere with Genuity Science’s human resources policies and procedures as well as participation in staff review programs within the organization.

Qualifications

  • Minimum Bachelor’s degree in a science, quality management or related field.
  • Minimum 10 years’ working experience in a clinical laboratory setting.
  • Minimum 5 years’ experience as a quality supervisor in a clinical laboratory.
  • Proven experience in ISO15189, CAP and CLIA accreditation standards.
  • Proven experience in US and international molecular based clinical trial protocols to standards such as Good Laboratory Practice and Good Clinical Practice.
  • Proven experience generating, maintaining, and revising SOPs, specifications, validations, procedures, batch records, training, non-conformance records, and other documentation systems.
  • Strong understanding of HIPAA privacy laws and laboratory biosafety guidelines.
  • Proven experience in preparation and hosting onsite pharmaceutical and third party audits and conducting vendor audits.
  • Proven track record in laboratory/clinical quality management system implementation with subsequent attainment of accreditation status, to include reaccreditation.
  • Advanced technical, analytical, and problem-solving skills. Able to evaluate quality metrics, trend analyses, and business problems and identifying appropriate solutions.
  • Experience in the validation of laboratory infrastructure such as laboratory information systems and electronic quality management systems.
  • Proven project management experience.
  • Outstanding attention to detail and organization skills.
  • Excellent written and verbal communication skills.
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EEO Policy Statement: It is the policy of Genuity Science to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Genuity Science will provide reasonable accommodations for qualified individuals with disabilities.

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Improving Lives Through Genomics

At Genuity, our mission depends on the shared commitment of our people, dedicated to helping us create a new reality for the future of health.

We serve the world’s leading life sciences companies including biotechnology, pharmaceutical companies and medical research centers. Our partners all use insights from genomic data to improve health. Our capabilities include providing access to population-scale patient cohorts for research, next generation sequencing (NGS) CLIA/CAP GCP labs globally, and a team of the world’s leading A.I. and genomic analysis experts and technologies for organizing, mining and sharing genomic and disease biology data.

Employee Benefits include:

Medical, Dental, and Vision Insurance

Life / Accidental Death & Dismemberment Insurance

Short and Long Term Disability Insurance

Pet Insurance, Legal Insurance

Flexible Spending Account (FSA)

Generous 401(k) Matching Program

Employee Assistance Plan (EAP)

Commuter Reimbursement Program

Employee Referral Bonus Program

Tuition Reimbursement Program

Cell Phone Usage Reimbursement

Reservable Bicycles