Quality Assurance Years Experience

KATHY HABER

**** ***** ***. **********, ** ****7 513-***-**** abmhq1@r.postjobfree.com

Regulatory Affairs Associate with over ten years experience writing CMC

documents for ANDA and other FDA submissions, revised labeling records,

reviewed manufacturing and packaging records and wrote annual reports.

SUMMARY OF QUALIFICATIONS

• Over fifteen years experience in pharmaceutical regulatory affairs industry writing labeling

sections for ANDA submissions and supplements; compiling manufacturing and packaging

documents, raw material and packaging specifications, and test methods for new ANDA

submissions.

• Compiled a new ANDA submission with a 14-month approval period with one test method

deficiency, and 180 day exclusivity for first to file status.

• Wrote CMC documents for new drug submissions, amendments and supplements for

several generic drug products. Wrote annual reports for

• Worked with the FDA during audits and inspections.

• Responsible for reviewing, auditing, and inspecting clinical manufacturing and packaging

documents and manufacturing equipment.

• Over ten years experience in pharmaceutical research and development and consumer

cleaning products laboratories.

CAREER ACHEIVEMENTS

REGULATORY AFFAIRS CONSULTANT

• Wrote labeling documents for a pharmaceutical company in California.

QUALITY ASSURANCE/REGULATORY AFFAIRS

• Audited/reviewed manufacturing and packaging documents, specifications and test

methods; managed change controls; obtained client approvals on required documents.

• Established strong working relationships with several external clients for a contract

manufacturing/packaging company for document control, complaints and FDA

submissions.

• Managed Complaints Department for two years establishing priorities,

investigating and writing reports for clients; handling returned product according to FDA

and DEA regulations, establishing off-site storage of completed complaint reports

according to FDA regulations.

• Wrote CMC documents for external clients for FDA submissions.

• Wrote and reviewed Standard Operating Procedures for quality assurance,

regulatory affairs, and complaints department.

CLEANING VALIDATION SPECIALIST

• Developed test method Using TOC analysis for drug substance and cleaning product

residues.

• Established cleaning validation protocols, established allowable residue limits for drug

substances and cleaning products, calculated product contact surface areas for all

manufacturing equipment.

• Wrote Standard Operating Procedures for cleaning validation.

EDUCATION AND TRAINING

Associate of Science (A.S.) Degree in Science Technology

University of Cincinnati

Currently pursuing A Bachelor of Science in Business

Estimated completion June 2012

PROFESSIONAL EXPERIENCE

Regulatory Affairs Consultant

K Haber Consulting, LLC

August 2009 – Present

Quality Assurance Associate

Patheon Pharmaceuticals

February 2005 – July 2009

Regulatory Affairs Associate

Watson Pharmaceuticals

March 1996 – February 2005

Cleaning Validation Specialist-Scientist

Duramed Pharmaceuticals

October 1993 – March 1996

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