Quality Systems Specialist II

Summary:

Supports compliance, maintenance and improvement of the global quality management system. Assists in all quality system activities. Supports development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and internal corporate requirements.

Project Details:

• Actively participate in audit preparation efforts by supporting planning, gap analysis, and mitigation implementation activities required to comply with new regulations and standards.
• Responsible for supporting generation of QMS documentation using Electronic Document Management System (EDMS).
• Support coordination of document and record retention program for the site in alignment with the internal corporate requirements.
• Write and revise Quality Systems procedures, perform gap assessments and assist in driving compliance.
• Exposure to internal, external, laboratory, supplier auditing programs as appropriate.
• Maintain processes/procedures to ensure compliance to internal and external requirements.
• Provide compliance support for Quality Assurance, Regulatory Affairs, R&D, and Operations to assure regulatory compliance and appropriate business planning.

Job Experience:

• Understanding of manufacturing procedures and GMP requirements is a plus
• Experience in Change Management, Inspection and CAPA Management is an added advantage
• A proven ability to work creatively and analytically in a problem-solving and process-oriented environment
• Expected to operate independently, accountable to proactively fulfill tasks and achieve results within assigned timelines
• A proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives

Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefitsgroup@oxfordcorp.com . We will make a determination on your request for reasonable accommodation on a case-by-case basis.