Quality Assurance Compliance Investigator
3 weeks ago
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.
- 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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