JT706 - COMPLIANCE QUALITY SUPERVISOR
Aibonito, Puerto Rico
Seasonal
Medical Device
Experienced
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Responsible for the oversight of Internal Audits related activities (including corrective actions, preventive actions, effectiveness checks, and Observation Certification Program) to ensure timely completion and closure as per Global and local requirements.
- Maintain updated the Aibonito Facility Inspection Readiness Plan.
- Maintain updated the Aibonito Site Master File.
- Ensures the Observation Certification Program is executed as per requirements, preventive actions are identified, and any gaps are identified and addressed until resolution.
- Maintains the on-time data gathering for the site Key Performance Indicators (KPIs) and drives improvement through the identification of preventive actions and improvement activities.
- Ensures the timely completion of the Management Review presentation and ensure presented data is aligned with global and local requirements.
- Performs the Annual Product Quality Report (APQR) final reports and ensures these are uploaded in TCU system for timely approval.
- Assure all documentation performed in the area is complete, accurate, and in compliance with the procedures, specifications and regulations.
- Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed.
- Observe confidentiality and data privacy rules at all times.
- Be a facilitator of Manufacturing and Quality Improvement projects.
- Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
- Submit changes (improvements and/or modifications) to specifications and Standard Operating Procedures.
- Responsible for review changes in specifications and SOP's under CDR system.
- Provide support and/or manage non-conformance investigations (NCR, CAPA, etc.) and NCRs related to the Internal Audits area.
- Interact under minimal supervision with various Local and Divisional function groups.
Qualifications:
- Bachelor's degree in Science or Engineer discipline. Other bachelor's degrees may be considered if it is commensurate with experience in Quality Assurance, Quality Control or Documentation Center.
- 5 years of experience in related area.
- Experience in Medical device industry preferred
- Must have the ability to manage people, encourage teamwork and drive decisions.
- Excellent verbal and written communication skills.
- Knowledge of statistics is preferred.
- Proficiency in computer software such as Microsoft Excel, PowerPoint, Word, or similar tools.
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Apply for this position
Required*