Quality Assurance Compliance Investigator

3 weeks ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Title: Quality Assurance Compliance Investigator

Lynkx Staffing LLC is seeking a Quality Assurance Compliance Investigator to join our team in Allendale, NJ. As a Quality Assurance Compliance Investigator, you will be responsible for performing Quality Assurance Compliance activities in support of company and/or client procedures, including document management, investigations, CAPA, SOPs, qualification and validation reports, and QC data.

Key Responsibilities:
  • Liaise with relevant functional groups to conduct investigation and CAPA processes.
  • Conduct investigation and identify true root cause using appropriate tools.
  • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates.
  • Reviews and approves investigations and CAPAs when required.
  • Collaborate with cross-functional departments to develop and track CAPA plans.
  • Prepare and issue change control as necessary.
  • Adhere to all compliance regulations as required by regulatory agencies and per the Company's processes and procedures.
  • Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
  • Conduct trend analysis of compliance-related metrics such as deviations and CAPAs.
  • Perform supplemental investigations and/or participate in project teams or assignments as necessary.
  • Support in agency, internal, and/or client audits.
Requirements:
  • B.S in biological sciences or other relevant field of study.
  • Minimum 5 years' experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
  • Experience in authoring, reviewing, and/or approving cGMP/cGTP-related documents (Investigation report, CAPA report, SOPs, etc.) required.
  • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
  • Familiar with FDA, ISO, and other regulatory agency guidelines.
  • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP) required.
  • Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
  • Experience in both clinical and commercial manufacturing is preferred.
  • Experience in supporting health authority inspections and/or client audits preferred.

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.



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