Quality Assurance Compliance Investigator
4 months ago
- 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.
- 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.
- Competencies/Candidate Profile
- Relevant computer skills (Microsoft Office, Outlook)
- Detail-oriented and organized
- Analytical and problem-solving skills
- Good written and oral communication skills
- Ability to multi-task and be adaptable
- Flexible and able to adapt to company growth and evolving responsibilities
- Ability to work independently and with a team
- Strong Project Management and organization skills
- Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.
- Must be able to work in a team-oriented environment.
- Must be able to work occasional weekends, nights, and/or holidays as required/necessary.
- May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
- Must be able to handle the standard moderate noise of the manufacturing facility.
- Must be able to work in open floor plan environment and may work in close proximity to others.
- Wheel-o-Vator available for use.
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