Quality Compliance Specialist

The Quality Compliance Specialist supports quality compliance systems and objectives within the site.  Responsible for conducting the internal audits and the CAPA Tracking.  Participates in the Inspection Readiness Team, assessment of compliance with domestic, foreign and corporate regulations, guidelines and policies relevant to Good Manufacturing Practices.   Perform External Audits to Suppliers as needed, handle and assist Site QO during regulatory inspections, fulfil request to support regulatory registration submissions and post approval CMC.  Assure site adherence to FDA among other worldwide regulatory agencies. Approver of Complaint investigations and Annual Product Review Report, contributor and approver as well as SOPs.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Lead auditor for Independent Business Monitoring program (internal audit)
• Manages site audit plan, including issuing audit reports and communication to managers; tracks audit commitments and manages monthly reporting.
• Develops, implements, and ensures completion of site Integrated Audit Plan for external and regulatory inspection, providing monthly status update to Quality Council.
• Assist in Field Alert Report preparation as needed.
• Participates in walk-throughs, IR Gembas and PAI 
• Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits, including audit readiness assessments.
• Acts as scribe/ monitor or strategist for FDA/DEA, foreign and/or third-party site inspections.
• Manages audit follow-up, including participating in root cause analysis (where required), reviewing and agreeing CAPA plan and monitoring CAPA effectiveness.
• Participates/assist/write inspections responses.
• Keeps tracks of regulatory commitments and site inspection response commitments monitoring for timely completion. 
• Stays current with all relevant Federal, state, foreign, and corporate regulations, guidelines, and policies and industry trends.
• Analyses and interprets compliance information independently.
• Provides documentation for filing as requested by GMC or market RA to support submissions or renewals.
• Support response to queries from regulatory agencies for regulatory filings or product license renewals, as needed.
• Site licenses/ registration submission and renewals (pharmaceutical industry registration, FDA, Food Facility Registration, etc.) on time.
• Handles regulatory queries from different markets.
• Review and approval of complaints; assist in coordination of complaints program and trending of complaints as needed.
• Generate and approve Product Record Review data contribution.
• Supports manager in the preparation of presentation, minutes and action logs of the Quality Council meetings.
• Work together with the team to assure that QO objectives goals are met.
• Keep appropriate site/corporate management informed of compliance status via Real Time Notification and Product Incident Management,
• Review and approve commitment actions.
• Participate as Subject Matter Expert (SME) for SOPs review and approval.
• Assist in the review of risk assessments for projects/suppliers’ audits, quality agreements review and suppliers' documentation.
• Provide trainings as needed.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Associate’s degree in science (biological sciences, chemistry, pharmacy or related scientific discipline)
• Experience in Pharmaceutical Quality Assurance and Quality Compliance

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor’s degree preferred
• Certified auditor preferred
• 5 years’ experience in a GMP environment.
• Previous experience on systems
• Working knowledge of pharmaceutical facilities, equipment and systems.
• Highly effective oral and written communication skills.
• Knowledge of QMS, cGMPs, and other relevant standards.
• Computer literacy with the ability to compile and generate graphs and key performance metrics in MS Office Suite or comparable software