ANNE M. ROBINSON

*** *. ******* **. ******** WI

920-***-****

QUALITY MANAGEMENT ● AUDITING ● REGULATORY COMPLIANCE

ASQ Certified Quality Auditor ASQ Certified Biomedical Auditor ASQ Certified HACCP Auditor

RABQSA Certified ISO 9001 and ISO 13485 Lead Auditor training 2012

ISO 17025 Lead Assessor training 2013; GCP and Drug Development 2004

Quality Systems implementation for GMP manufacturing and for 17025 independent testing lab.

Raw material, in-process, stability, and finished product testing/release of parenteral, oral liquid, lyophilized drugs and Class I and II medical devices, aerosols, cosmetics, and consumer goods. QUALITY MANAGER, SGS-IPS TESTING SERVICES, APPLETON WI March 2013-Present

Administered the Internal Audit program for ISO 17025/ISO 9001 and cGMP compliance.

Expanded the ISO 17025/ISO 9001 scope of accreditation successfully 2013- 2016.

Directed calibration, document control, CAPA, lab productivity, training, and safety programs.

Percentage of CAPAs open-to-close in 40 days or less went from 48% in 2013 to 89% in 2015.

Training: averaging ~90% on-time compliance in 2013 to >99% in 2015-16.

Led management review and subcontractor/customer/third-party/internal audits. QUALITY MANAGER, IKI MANUFACTURING CO., INC., Edgerton, WI Dec 2005 to Mar 2013

Hired as QC Lab Manager; within 6mo took over Quality System Manager duties and subsequently production QC Manager over two plants (6 aerosol production lines and 1 silk screen line).

Batch record review, COA/COC writing and approval, APRs, Complaint investigation/resolution.

Lead Auditor for FDA inspections and 483 resolution (2007, 2009, 2010).

Customer/Third Party Audits resulted in Best in Class status (WD40, 3M, Bayer Health Care).

Excellent communication skills with supporting production departments (engineering/technical/formulation) and implementation of waste reduction techniques (reject classification, yield/overfill, and downtime analysis) resulting in consistent <0.5% reject rate over six production lines in one year (down from 4%).

Managed Quality Control Laboratory for regulatory compliance and testing reliability, trained lab technicians, improved traceability, recommended/approved equipment purchases. QUALITY CONTROL SUPERVISOR, PRECISION DOSE, INC. SO. BELOIT IL QA AUDITOR/SOP ADMINISTRATOR, COVANCE CRU, MADISON, WI COMMERCIAL STABILITY SPECIALIST, STERIS LABS, PHOENIX, AZ SENIOR STAFF SCIENTIST, NORTHFIELD LABORATORIES, MT PROSPECT, IL R&D SUPERVISOR, ZENITH PARENTERALS, INC., ROSEMONT, IL R&D SCIENTIST I & II, LYPHOMED, INC., MELROSE PARK, IL OTHER MANAGEMENT EXPERIENCE: Owned and operated two tavern businesses successfully for over ten years. Brought condemned building/business into TIF district building code, restaurant health code compliance, and operating at a profit within 9 months of purchase.

LOYOLA UNIVERSITY OF CHICAGO LAKESHORE, Bachelor Degree - Chemistry, Math Minor