Quality Assurance Compliance Specialist
3 weeks ago
- Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes.
- Develops and communicates investigation strategy to key stakeholders.
- In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log
- Reviews and approves investigations and CAPAs;
- Conducts weekly status update meetings with cross functional departments and other stakeholders.
- Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis.
- 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.
- Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
- Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
- Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles.
- Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
- BS biological sciences or other relevant field of study.
- 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.
- Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training
- Understanding and comprehension of quality system applications.
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