*** ********* ****** ***** *. Gotler

St.Augustine, FL 32095 ad4fol@r.postjobfree.com Cell: 704-***-****

CAREER SUMMARY

Quality Systems professional with complete responsibility as the primary host for training /educating internal sales departments as well as customers both new and old on FDA, DOT, EU and other international regulatory agencies regarding cGMP compliance and ICH guidelines. Well honed presentation skills, with hands on extensive knowledge of FDA, cGMP, ICH and ISO quality guidelines. Establishing limit standards, physical standards, communicating operational standards with the customer. Project lead on 100's of projects every year for being lead technical representative for both new launch and or re-packaging both glass and plastic packaging to nationally branded pharma, healthcare, food and nutraceutical customers. Establishing Corporate SOP's for assuring that all aspects of all approvals pertaining to the development, sampling and release of production orders followed a best practice, methodical protocol. Driving continuous improvement through metrics; communicating quality philosophies to all internal and external staff.

CORE COMPETENCIES

Global Regulatory Compliance Lead Auditor for New and Old Suppliers

Glass manufacturing design development Quality Financial Metrics

Plastic engineering/design and development Multi-site Operation Experience

cGMP Compliance PS labeling, silk screen decorating expertise

PROFESSIONAL EXPERIENCE

O.Berk Company, LLC- Union NJ

Director Technical Services

June 1995- March 2017

Reporting to the Supply Chain Director, and the President, I had the responsibility for and authority over the company's corporate SOP’s, cGMP documents. I was the author for all CAPA response letters to our customers, to ensure that they were both effective and closed with appropriate actions. The direct liaison between our sales, team, our customers and O.Berk's 300 plus suppliers to ensure that we effectively communicated each suppliers quality standards to our clients and set physical limit standards to better match the customers’ expectations to the process/equipment. Demonstrated ability to work across the supply chain, with resourcefulness, fairness, exercising good judgment, targeting on time delivery, at the agreed upon price.

RESPONSIBILITIES

Top influencer for all new glass and plastic rigid packaging projects including; custom injection, extrusion and or compression molded packages as well as Type I and Type III glass packaging. Responsible for all corrective and preventative action plans affecting vendor quality processes. Lead for all project management for Proctor & Gamble, Estee Lauder/ Bumble and Bumble line of packaging products.

Identify compliance risks to management with remediation proposal, and lead solution implementation for document control issues.

Write, revise, and approve SOPs as necessary.

Provides timely support and direction to our vendors, our purchasing department and VP Sales and Marketing. Participates in the development of standard work practices and/or SOPs to ensure high and consistent level of quality. Provides training to department staff in standard work and/or SOP specifics as required.

Manages QA Compliance department to ensure that investigations/CAPAs are closed with appropriate actions.

Provide compliance support, expertise and training for all impacted departments.

Leads self-check internal audits and provides immediate support for regulatory audits.

Host for all customer and third party audits.

In house technical training programs for all sales/sale service personnel.

A.Q.L. Decorating Company, Inc. Fairview, NJ

Quality Assurance Manager

June 1980- June 1995

Responsible for managing /training 15 inspectors for a national contract decorator.

Hands on trouble shooting expertise on rotary hot stamping, Shorewood and Label-Aire PS labeling equipment as well as the Omso Axial decorating system.

First piece inspection approval, excellent color matching skills, artwork proof reading, final approval on all machine set-ups. 20 changeovers on any given day was commonplace.

In the 15 years of service at AQL, the check and balance system and recurrent training programs brought even greater added value to the company's reputation as a leader in contract decorating services.

Packaging Associates of Connecticut- Watertown, CT

Operations Manager

August 1976- June 1980

P & L responsibility for vertically integrated extrusion/injection blow molding and in house contract decorating company (silk screening, hot stamping)

Acquisition manager - three acquisitions over the course of 5 years.·

Budget, cost controls,· Hiring and firing of all personnel.·

Coordinated production, quality control and maintenance to obtain optimum production and utilization of human resources, machines and equipment.

EDUCATION

University of Hartford- AS Degree

University of Connecticut- NutritIonal Science

PERSONAL & PROFESSIONAL DEVELOPMENT

Microsoft Office and associated software- Access, Excel Word

Salesforce Dot Com project software Member of ASQ and SQE

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