ROBINANN GERBINO

** **** **** ****** **** Park, New York 11729 Cell Phone 631-***-****

Email: adpwh4@r.postjobfree.com COMPUTER SKILLS

Proficiency includes Microsoft Word, Excel, Quark Express, PowerPoint, Microsoft Access, Microsoft Outlook, Internet Navigation, Inventory Software, Quality System Software Other Skill ISO Compliannce

FOREIGN LANGUAGE

Spanish

EMPLOYMENT

W. S. Wilson, Port Washington, NY Quality Control Supervisor 2017-2018

Supervising Quality Inspectors Inspecting QC Inspectors for incoming an final finished product inspections: reviewing and approving documents for final release.

Nature’s Bounty, Bohemia, NY Documentation Control-Supply Chain Executive 2016-2017 Contract

Receiving and reviewing documents for dietary supplements and cosmetics for dossier submission. Trained for HACCP AND sop implementation.

Biochemical Diagnostics, Edgewood, NY Quality Assurance Manager 2016-2016

Supervising, and training all QA Inspectors regarding cGMP’s, (according to 21 CFR) SOP’s (i.e SOP for Risk Management) and monitoring all, packaging lines for medical devices

Releasing labels, raw materials and components for manufacturing,

Monitoring stability program and updating management regarding out-of-specification results.

Following-up and closing CAPA’S.

Altaire Pharmaceuticals, Inc. Riverhead, NY 2009-2016

Quality Assurance Manager Promoted from Quality Assurance Supervisor to Quality Assurance Manager

Implementing, developing and training a Quality Assurance Department Eliminated product returns due to out-of- specification customer AQL’s

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Supervising, and training all QA Inspectors regarding cGMP’s, (according to 21 CFR) SOP’s (i.e SOP for Risk Management) and monitoring all sterile, non-

sterile, and packaging lines, Releasing labels, raw materials and components for manufacturing.

Monitoring stability program and updating management regarding out-of-

Specification results, Monitoring stability studies for all drug products (OTC’s, ANDA’s, 510K’S,

Preparing and approving protocols for process validation, stability and cleaning, and sterility

Preparing and reviewing Annual Product Reports,

Preparing Environmental monitoring reports for non-viable, viable and personnel bioburden,

Preparing components for sterilization,

Investigating and responding to customer complaints. Also implementing CAPA when required, investigating Out-Of-Spec. Results

Preparing stability protocols for FDA approval.

Preparing and approving change controls for ANDA drug products.

Preparing raw materials and components for annual requalification

Country Life, Hauppauge, NY 2006-2009

Regulatory Affairs Associate

Instrumental in developing, implementing SOP’s for regulatory functions

Preparing, developing, implementing and training regulatory personnel for SOP’s regarding current Dietary Supplements for FDA compliance,

Responding to customer inquiries,

Validating all structure function claims through navigating the internet and preparing reference sheets/ letters for FDA submission,

Developing, preparing and reviewing all new product labels and current product labels for final release,

Confirming all regulatory documentation i. e. cosmetic, allergens, GMP, certificate of analysis, specifications, material safety data sheet, nutritional information, certificate for all product ingredients.

Preparing Dossiers for international submission.

8 in 1 Pet Products, Hauppauge, NY 2005-2006 Quality Assurance Inspector

Inspected all products during manufacturing and packaging,

Performed blister pack analysis,

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Inspected blister packs for appropriate seal closure,

Maintained all quality assurance files.

Time-Cap Labs, Inc., Farmingdale, NY 1998-2003 Regulatory Affairs Manager

Instrumental in eliminating all FDA deficiency and reduced customer complaints by 50%

Prepared, developed, implemented, trained personnel for cGMP’s/SOP’s, according to 21 CFR)

Prepared and submitted documents for drug product foreign registration submission,

Prepared and submitted drug product listing,

Prepared and reviewed Annual Product Reviews and Reports,

Released drug products containing DEA List 1 Chemicals,

Prepared and reviewed change controls,

Reviewed drug product labels for release,

Assisted in FDA audits.

Per/Pak Orlandi, Inc. West Babylon, NY 1996-1997

Quality Control Manager

Prepared, developed, implemented and trained personnel for cGMP’s/SOP’s,

Performed internal audits.

Citation, Inc. Farmingdale, NY 1995-1996

Quality Control Manager

Prepared, developed, implemented and trained personnel for cGMP’s/SOP’s,

Performed internal audits.

Tishcon, Corp., Westbury, NY 1992-1994

Quality Control Manager

Prepared, developed, implemented and trained personnel for cGMP’s/SOP’s,

Performed internal audits.

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EDUCATION

Masters in Business Administration, Adelphi University

Bachelor of Arts in Social Science, Adelphi University

Associate Degree in Medical Technology, Farmingdale, (S. U. N.Y)

ORGANIZATIONS

Regulatory Affairs Association for Regulatory Affairs

American Society for Quality

Courses for Quality Assurance

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