Quality Control Assurance

AWILDA ORTA-GERBER, RAC

West Palm Beach, FL *****

954-***-**** (Mobile) abm0tr@r.postjobfree.com

PROFESSIONAL PROFILE

Regulatory Affairs, Compliance and Quality Assurance professional with proven track record and expertise in:

• Implementation of Quality Systems • Green Belt Six Sigma Certification

• Regulatory Submissions • FDA GMPs/QSR, ISO9001/13485, CLIA

• Root Cause Investigation, SPC, DOE • Published Technical Author

• Quality Control and Manufacturing • Bilingual – Fluent in English and Spanish

• Medical Devices and Licensed Biologicals • Hosting External and Internal Auditors

PROFESSIONAL EXPERIENCE

Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson Company 1998-2010

Pompano Beach, FL

Regulatory Affairs Associate III (2007-2010)

Responsibilities: Planned, prepared and submitted to the FDA and other Health Authorities regulatory

submissions for Class II medical devices and licensed monoclonal reagents. Negotiated diverse regulatory

strategies as Site FDA liaison. Led complex RA strategies for multidisciplinary project teams across sites.

Performed regulatory reviews of technical reports, validation test plans, scientific data analysis, design changes

and external labeling. Served as member of the site leadership team, which developed long-term strategy and

direction for the site.

Accomplishments:

• Established site Regulatory Affairs department in alignment with headquarters’ procedures.

• Reduced cycle time by 50% with one time savings of $9K obtaining PAS approval from CBER.

• Led project for electronic instructions for use which saved approximately $80K in paper insert costs.

• Led and coordinated site team through multiple FDA inspections with successful results.

• Maintained excellent approval track record for PAS, CBE, CBE-30, CMC, Annual Reports, 510(k)

submissions.

• Led team to harmonize and streamline regulatory assessment procedures across the global organization.

Supervisor-Principal Scientist – Complaint Handling Unit (CHU) (2003-2007)

Responsibilities: Directed daily activities of CHU personnel (4) including root cause investigation, maintained

complaint files, performed complaint trending and failure investigations, prepared health hazard evaluations and

risk-benefit analysis, Medical Device Reporting (MDR) and BPD reporting.

Accomplishments:

• Established site CHU in alignment with headquarters’ procedures and FDA GMPs.

• Led multiple product failure root cause investigations using statistical tools (FMEA, DOE, SPC).

• Turned around monthly complaint closure metrics (from <60% to >90%) .

• Led and coordinated staff during FDA inspections and other auditors supporting front and back rooms.

• Developed and implemented process for the return and investigation of product involved in complaints.

• Developed and implemented complaint trend report template for the global organization.

• Designated as site trainer for six-sigma, complaint handling and diversity.

Quality Control Laboratory Supervisor (1998-2003)

AWILDA ORTA-GERBER

954-***-**** (Mobile) abm0tr@r.postjobfree.com

Responsibilities: Directed daily activities of Quality Control (QC) Laboratory personnel (6) responsible for

product release testing and led the investigation of product quality issues through extensive design of

experimentation. Performed supplier audits and interacted directly with FDA, ISO and other external auditors.

Accomplishments:

• Resolved compliance gap by writing, implementing new SOPs, such as test methods, RCI and CAPA.

• Successfully facilitated and supported integration with new parent company

• Managed and prepared multiple project plans for equipment and process validations

Central Florida Blood Bank, Inc. / Central Florida Tissue Bank, Inc. 1990-

1998

Orlando, FL

Compliance and Regulatory Affairs Manager and Technical Training Coordinator (1992-1998)

Responsibilities: Established the new QA department, performed internal audits and coordinated multiple FDA

inspections. Submitted and managed regulatory correspondence. Directed and developed 3 employees.

Accomplishments:

• Established internal audit plan and completed > 100 internal audits

• Developed, coordinated and delivered comprehensive training and continued education programs

Sr. Medical Technologist (1990-1991)

Responsibilities: Led shift (5 employees) in the Transfusion Services Department for a Level 1 Trauma Center

Maryland Medical Laboratories, Inc. 1988-

1990

Baltimore, MD

Medical Technologist

Responsibilities: Performed Clinical Immunology screening and diagnostics tests.

EDUCATION AND TECHNICAL TRAINING

• MBA – University of Phoenix, Phoenix, AZ

• BS, Medical Technology – Marquette University, Milwaukee, WI

CERTIFICATIONS / LICENSURE

• RAC

• Green Belt Six Sigma Certification

• MT(ASCP)SBB, CLS (NCA), AABB Auditor

MEMBERSHIPS

• Regulatory Affairs Professional Society (RAPS)

COMPUTER SKILLS

• Word, Excel, PowerPoint, MS Project, Access, Minitab, Cognos, Visio, PB Views, Trackwise, OTIS

LANGUAGES

• Fluent in English and Spanish

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AWILDA ORTA-GERBER

954-***-**** (Mobile) abm0tr@r.postjobfree.com

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