The QA Compliance Investigator is responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients.

• Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) 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 department to develop and track CAPA plans.
• Prepares and issues change control as necessary.
• Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures.
• Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
• Performs supplemental investigations and/or participates in project teams or assignment as necessary.
• Support in agency, internal and/or client audits.
• Other duties as assigned.

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 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.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.