QA Manager in New Hyde Park, NY at Apex Life Sciences

Date Posted: 9/17/2018

Job Snapshot

Job Description


Quality Manager

Responsibilities

  • Establish, implement and maintain the Quality Management system and its procedures, required to comply with quality guidelines such as Good Clinical Practices, ISO & CAP guidelines and other pertinent regulations and standards, as agreed with senior management and as part of the Global Quality Management system.
  • Verify, in collaboration with the Global Director Quality Assurance that all procedures and working instructions are set up in compliance with the Global Quality Management System and the applicable quality guidelines.
  • Organize and provide training of personnel concerning the organization, the management system, and its procedures, applicable quality guidelines, IATA, HIPAA and local safety regulations (if applicable) and coordinate the organization of general training sessions provided to new and established employees; evaluate training needs and the effectiveness of trainings given
  • Audits:
    • Conduct internal and external audits, in accordance with the global audit schedule, to determine if the management system is compliant to the planned arrangements and the applicable quality guidelines, and to determine if the system is effectively implemented and maintained. External audits include, but are not limited to audits of the partner lab (on assay level and/or study level), referral laboratories or other subcontractors.
    • Write audit reports and prepare corrective/preventive action plans in collaboration with the head(s) of the audited department(s).
    • Present the company and its Quality System to visitors and external auditors.
  • Ensure follow-up on the implementation of corrective/preventive actions and their effectiveness
  • In collaboration with the Global Director QA, ensure each department implements relevant QC checks to ensure a high level quality of services.
  • Ensure that all complaints from both external as well as internal origin received are followed up and registered in the global complaint database
  • Assist the Global Director QA in performing QA review of analytical reports
  • In collaboration with the laboratory:
    • Ensure validation files are complete in case of the implementation of new tests
    • Discuss any laboratory issues raised by Operations and/or the QC&Lab Coordinator and follow-up on the root cause investigations, remedial, corrective and/or preventive actions

Requirements

  • Master’s Degree in science or equal by experience
  • Experience in different national and international quality standards (ISO, GLP, GCP)
  • Flexible in dealing with problems
  • Very detail oriented

FOR IMMEDIATE CONSIDERATION Please e-mail your resume to Marshena Moncrieffe at mmoncrieffe@apexlifesciences.com and contact our office at 631-249-5190 regarding the QA Manager Position.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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