Quality Manager

Donna Domingo

** ***** **** ( Monroe, NJ ***** 914-***-**** ( ********@***.***

Asociate Director of Quality

18+ Years of Proven Ability and Quality Expertise

Select Carrier Accomplishments

> Streamlined All Documentation, Deviation Reporting, CAPA, Training,

Qualification Protocols (approval and Executed documents) processes

in a paper-based system to decrease process time by 65%.

> Drove/implemented continuous improvement policies via a metric

reporting system in Quality functions

> Decreased change control processing time to 50% by working with the IT

department to develop an electronic Change Control system (2 phase

implementation) by completing second phase development of the Change

Control system. (G&W Labs)

> Increased commercial batch release to market 35% by evaluating the batch

review/audit process, eliminating redundancies, and keeping the system

within compliance.

> Provided compliant documentation to the FDA, resulting in a January 2012

FDA general inspection without a 483 write-up.

> Developed an APR system (existing APR was insufficient by industry

standards) and revised the company standard operating procedure (SOP)

process to meet cGMP requirements.

> Returned the company to VAI status through remediation with the FDA by

creating and implementing a training system.

> Avoided costly FDA observations by developing a company-wide

comprehensive training system and individual curriculums.

> Commissioned, validated, and administered an electronic APR System that

functioned in real time and was utilized by all respective departments to

enter data and ensure data integrity.

> Contributed to company savings of >$300K by leading and completing the

development of a compliant change control system and process flow.

Maintained the position of Documentation Specialist/APR Coordinator

and was later offered a position of Regulatory Compliance Associate

following company acquisition.

Professional

Experience

Associate Director of Quality, Aurex Labs, East Windsor, NJ

January 2015 - present

Start-up OTC facility, Gel Caps, Solid Oral dosage and development of NDA's

for Gel Cap applications

Quality Assurance Manager, Hemispherx Biopharma Inc, New Brunswick, NJ

October 2012 - January 2015

. Approve Change Controls and Deviation Reports; recommend corrective

action as required

. Conduct In-house CGMP training, Assist Regulatory Affairs Department

with FDA inspections and submissions

. Coordinate and recommend improvement initiatives and quality policy

. Oversee development of company Master Validation Plan

. Review and approve Validation Protocols and Reports

. Prepare Annual Product Reviews, Approve company SOPs, Master Batch

Records, Stability Protocols and Reports, Test Methods and

Specifications

. Conduct audits for internal operations, contract manufacturers,

testing labs, and suppliers,

. Assist with preparation of CTD

. Oversaw clinical supplies labeling, shipping and documentation for

double blinded studies

Sr. Manager of Quality Systems, G&W Laboratories, South Plainfield NJ

September 2011 - February 2012

Completed development of phase II Change Control System, a hybrid

electronic Change Control System and process flow. Through my

development of this initiative this reduced the process time of the

Change Control document life cycle to 50% of it's original process

time

Developed a company wide comprehensive document retention

system/process, to maintain compliant document control

Developed efficient batch audit, batch release process, increasing

commercial batch release to market by 35%

Held key role in managing the company Quality Systems and providing

compliant documentation to the FDA during the latest general

inspection which resulted in a January 2012 FDA general inspection

without a 483 write-up

Collaborated with Quality Compliance in identifying root cause of

deviations (i.e. OOS, OOT, Environmental and Equipment deviations

etc.), assisted in CAPA evaluations, assignment and investigation

closure, which significantly decreased investigation closure turn

around time

Created and maintained Quality Manual

Lead weekly QRB meetings to provide cross departmental

assessments/resolutions of quality issues that impacted product or

processes

QA Manager of Document Control, G&W Laboratories, South Plainfield NJ

September 2009 - August 2011

Complete development of a compliant Change Control System and process

flow, through my leadership and development of this initiative the

company saved minimally $300,000, the cost of an EDMS (electronic

document management system)

Drove quality related decisions, with appropriate approval authority

(both data-based and risk-assessment-based decisions) to maintain

quality compliance

Complete development of a Training process / system and database

providing a proactively trained team avoiding costly FDA concerns.

Created a compliant Methods and Specifications versioning system (raw

materials, finished product, stability and components) to assure

unambiguous acceptance criteria / requirements

Developed, supported, & maintained departmental SOPs and Quality

System processes, as required, insuring robust and complaint processes

throughout the company

Developed and maintained robust APR (Annual Product Review) reports.

Qualified and implemented an electronic APR system, which provided

cross department functions, in real time with shared visibility. This

provided respective department's full visibility of current and past

product / process to assess for product / process improvement and

verification of data.

Performed company wide cGMP training and training on core Operational

and Quality SOPs

TEVA / BARR / PLIVA Inc. Pharmaceuticals New Jersey / New York

February 2004 - September 2009

Regulatory Compliance Associate,

2008 - 2009

Compiled APR for all residual Barr / Pliva products

Compiled non-conformance Trending Reports

Complied Vendor Qualification reports for all TEVA raw materials

Maintained APR system for residual Bar / Pliva products

Document Control / APR Coordinator

2004 - 2008

. Compiled all APR (Annual Product Review) data submitted by required

departments, to compose Executive Summary report, Quality Control

summary, Production History summary and Production Yields summary

Reports for a product line of 60 products

. Created controlled process flow for issuance and distribution of SOPs

. Developed databases for SOPs, Change Control, Methods and

Specifications for tracking and trending purposes

. Created comprehensive metrics for all Documentation department

processes

. Performed internal audits of company wide controlled documents

. Developed a controlled system for all cGMP official forms/documents

. Technical writing of all department SOPs and review of company wide

SOPs

Alpharma Pharmaceuticals, Elizabeth, NJ

January 2000 - 2004

QA Specialist II

2003 - 2004

. Supported cross department project management with regard to facility

equipment qualifications

. Performed internal audits

. Review / approval of all facility equipment qualification protocols,

IQ, OQ and PQ.

. Assisted in protocol technical drafting

. Performed all vendor / contractor cGMP training

. Strong knowledge of cGMP

QA Technician

2000 - 2003

. Performed all QA In-process inspection responsibilities and functions

related to QA Manufacturing, Cleaning Validation and Packaging

processes.

. Performed batch record review/audit

DFG/Tyson Foods New Hampton, New York October

1997 - January 2000

Quality Assurance Supervisor/Coordinator

. Coordination and implementation of all HACCP (Hazard Analysis And

Critical Control Points) process and documentation within the

manufacturing process

. Trained all QA technicians and manufacturing operators in the HACCP

process

. Over saw all manufacturing operations and supervised 10 direct reports

. Responsible for release and/or quarantine of finished product and raw

materials

Educational

Background

Community College of Vermont, St Albans VT

1985- 1986

General Business Administration / Accounting

Accreditations

2005 - CQA, Certified Quality Auditor, American Society of Quality

2004 - Kempner Tregoe certification in Problem Solving and Decision Making

2003 - OSHA Certified in General Industry Safety & Health

2000 - Certified in Plant Sanitation by AIB Food Safety & Hygiene

2000 - Certified in HACCP (Hazard Analysis and Critical Control Points)

1999 - Certified in CTFS (Commitment to Food Safety) and GMP

Computer

Skills

Microsoft Office Suites: (Access, Word, Power Point, Ootlook, and

Excel), Fox Pro, MS Project, Documentum, Lotus Notes, SAP, GXPharma,

TrackWise, QMAS, SharePoint, Amega Temperature Monitoring System

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