Quality Assurance

Anyio Ateghang

PROFESSIONAL EXPERIENCE

PharmaForce Inc., Columbus, Ohio Oct 2014 – Apr 2015

Quality Auditor

Scheduled, planned, executed, wrote up, followed up and closed internal and external audits. Supplier qualification.

Caraco (Sun) Pharmaceutical Laboratories, Detroit, Michigan Aug 2013 – Oct 2014

Sr. Quality Assurance Compliance Auditor

Managed the Quality System and ensured that procedures were followed and timelines were met. Managed the supplier quality system through external audits, and quality agreements.

Led quality review meetings with production, procurement, warehousing and quality control. Performed internal audits of the six major quality systems to comply with cGMP and FDA requirements.

Ensured that management was kept informed of the progress and outcome of audits/inspections.

Planned, scheduled, executed and documented both internal and external audits in a timely manner.

Tracked and evaluated corrective actions arising from audit observations.

Terumo Heart, Inc., Ann Arbor, Michigan Oct 2006 – Sep 2012

Compliance Specialist/Lead Quality Auditor

Developed procedures for the QMS and implement requirements and regulatory standards. Performed internal audits of the quality system to verify conformance to CFR 820, CFR 210, CFR 211, ISO 13485, ISO 19011 standards, other international standards as well as the requirements of internal SOPs.

Reviewed and analyzed the results of internal and regulatory audits. Audited for phase closure in the product development cycle. Reviewed batch records for product release.

Participated in defining and implementing the quality system for LVAD manufacturing.

Bone Care International, Madison, Wisconsin Nov 2000 – Aug 2006

GMP Specialist

Performed GMP audits of contract manufacturing and packaging facilities, production areas and laboratory procedures associated with the manufacture of sterile injectable and oral drugs products.

Prepared and revised Quality Agreements. Prepared Annual Product Reviews.

Third party oversight of the manufacture and packaging of parenteral and oral pharmaceutical products for GMP and quality compliance. Review of Master Production and Batch Records and supporting documentation for completeness (as defined by GMPs). Review and approval of validation protocols before execution and reports after execution.

Member of the CAPA team. Extensive interface with suppliers and contract manufacturers.

Ganes Chemical, Pennsville, New Jersey Apr 2000 – Nov 2000

Quality Assurance Auditor (Contract position)

Audited production log records for GMP compliance in the manufacturing, warehousing and distribution of bulk pharmaceuticals. Assured that all deviations and investigations were completed and that products were made under validated procedures. Approval or rejection of raw materials and intermediates that went into manufacturing.

Approval (or investigation) of final products for distribution. Review of the Certificate of Analysis of incoming supplies and products from suppliers and external partners. Ensured that our Product Labels and Certificates of Analysis were correct and in compliance with USP and FDA requirements.

Inspection (and release) of facilities and major equipment before and after use.

Schein Pharmaceuticals, Cherry Hill, New Jersey 1998 – 2000

Quality Assurance Inspector

Responsible for in-process QA inspection during the manufacture of sterile Penicillin and Penicillin derivatives (Ampicillin, Nafcillin, Oxacillin). Review and verification of the production batch records for compliance with cGMPs.

CERTIFICATIONS

Certified Quality Auditor (ASQ)

Certified Lead Auditor for ISO 13485.

EDUCATION

University of Minnesota – 4 years. Major – Microbiology.

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