ERNEST E. KELLY

E-MAIL acvj5d@r.postjobfree.com

*** ******** ******* **

East Stroudsburg PA 18302

PHONE 732-***-****

Professional Summary

Skilled professional with a B.S. in Chemistry, with a solid background in Quality Assurance and Internal and External Audits. Additionally strong understanding of, cGMP, CAPA, OOS ICH, FDA guidelines, ISO 9001:2015 Auditor Training and CFR 21Part 210 and 211

Professional Experience

Hayward Laboratories 03/03/2015-Present

Quality Assurance Manager

Ensuring compliance with national FDA policy, international standards and legislations as related to Good Manufacturing Practices (GMP).

Develop, implement, communicate, and maintain a quality plan to bring the company’s quality systems into compliance.

Managing and development and implementation of goals, objectives, policies and procedures pertaining to Quality Assurance, and ensuring that objectives are achieved.

Prepared plan, performed and maintain audit schedule for internal and external audits.

Audit Contract Manufacture to ensure that they meet Hayward Laboratories quality standards.

Maintain audit database for observations and audit CAPA.

Develop and deliver GMP/GLP Compliance training and participate with training and development of staff.

Manage technical QA Laboratory staff in carrying out raw material and production bulk tests/checks.

Manage Analytical Laboratory staff in carrying out testing of finished products and stability testing.

Organize and manage QA function in close cooperation with company’s management team and individual departments.

Monitor QA system and product quality by gathering relevant data and producing statistical reports.

Conduct and report out of specifications. investigations, product changes, and write reports to management about Corrective Actions and Preventive Actions (CAPA).

Managed batching auditors, to assure compliance with batching procedures. Responsible for production batch record reviews and QC line document review and retention.

Tekni-Plex Branchburg 03/2015-Present

Quality Assurance Manager

Managed and trained QA Associates, daily function relates to Quality Assurance department.

Manage the Internal and External audit teams.

Performs internal and external audits, to assure compliance with legal contracts, quality agreements, policies, procedures, FDA and cGMP regulations and guidelines

Developing and approving yearly audit schedules and expectations and assuring schedules are maintained and audit goals are achieved.

Report KPI

Conducted risk assessments.

Provided site leadership to the management of the daily process of opening new domestic and international complaint files, assigning complaints, updating the complaint database, tracking complaint investigations, generations of responses to customers worldwide using Compliant Pro.

Writing SOP’s, CAPA, Investigation reports.

Providing QA oversight of internal and external quality systems.

Ensuring accuracy, consistency and completeness of written audit reports.

Communicating findings to internal and external teams.

Ensuring implementation and establishment of appropriate timescale for corrective action plans.

U.S NONWOVENS Brentwood NY 07/2013-12/2013

Quality Assurance Manager Consultant

Managed and trained six quality assurance associates.

Good verbal and written communication skills, including SOP’s, validation protocol, CAPA, and OOS investigations.

Manage the Internal and External audit teams.

Performed internal and external audits, to assure compliance with legal contracts, quality agreements, policies, procedures, global FDA and cGMP regulations and guidelines.

Facilitate and manage training on cGMP and GDP.

Conducted internal and external audits of Plant and vendors.

Developed and implemented a comprehensive training program for laboratory and manufacturing.

Master batch records, validation protocols, change controls, deviations, investigations, product complaints and quality agreement contracts.

Troubleshooting quality and compliance related issues

Review, revise and approve material specifications for materials/components to ensure GMP regulatory compliance

Assure audits of pharmaceutical processes meet applicable requirements and that audits are conducted on a timely manner and are risk based.

Kerry Flavor & Ingredient Norwich NY 12/2012-07/2013

Quality Assurance and Technical Manager Consultant

Managed and trained twelve quality assurance associates, scientists and technicians.

Maintained the system for handling customer complaints on a timely basis and providing adequate written responses to complaints.

Manage the Internal and External audit teams.

Performs internal and external audits, to assure compliance with legal contracts, quality agreements, policies, procedures, global FDA and cGMP regulations and guidelines

Conducted internal audits and external audits for supplier audit program

Wrote reports verifying the effectiveness of all CAPAs for QC and manufacturing.

Ensured all microbiological testing for yeast and mold are within specifications.

Documented manufacture risk management and HACCP standards

Developed test schedule for raw materials based on the production requirements

Scheduled finished products testing for market needs

Innopharma Piscataway NJ

Quality Assurance Supervisor 11/2011-10/2012

Established a Quality Assurance Department

Trained and mentored eight quality assurance associates and scientists.

Conducted internal and external audits for contract manufactures

Responsible for maintaining documentation control, change control and CAPA system.

Maintained training records for GMP compliance training

Responsible for writing and reviewing CAPAs SOPs and OOS investigations

HH & P Lawrenceville NJ 02/2009-01/2011

Quality Control Supervisor

Supervised day-to-day scheduling related product releases to the market and testing of stability, finished products and raw materials.

Reviewed finished products, raw materials, bulk and stability samples and created analysis reports.

Maintained Laboratory service contracts for equipment in addition to service contracts for outside laboratory testing.

Performed review of laboratory data for accuracy and entered results into LIMS.

Trained ten Scientists and Technicians in cGMP, SOP and laboratory producers.

Served as liaison between quality assurance and manufacturing divisions as well as manager of laboratory issues.

GlaxoSmithKline, NJ 05/2002-06/2009

Product Development Scientist/Project Leader

Managed change control documentation using Trackwise system.

Directed team meetings with QA, QC, manufacturing, regulatory, marketing and business support.

Accountable for writing and reviewing stability, cleaning validation protocols, SOPs, OOSs, OOTs, method transfer and method development reports

Responsible for new product development and scale-up plant batches

Developed prototype formulae intended for clinical testing, consumer testing, pilot batch and new products.

Worked with cross functional teams to support new product development launches and product transfers.

Pliva Pharmaceuticals, NJ 06/2003-07/2006

Quality Assurance Supervisor

Ensured compliance with local, domestic, and international regulations for EU and JP for drug products.

Conducted internal and external audits for contract manufacture

Responsible for maintaining documentation control and change control management system.

Wrote and reviewed SOPs, OOS, investigations and CAPA.

Colgate Palmolive, Piscataway, NJ 12/1988-05/2002

Scientist Product Development Formulator - Skin Care

Formulation Scientist- Oral Care

Directly responsible for the launch of Colgate Total a semi solid formulation.

Worked on Colgate liquid formulation such a Plax and Colgate Mouth Rinse.

Worked directly with sourcing alternative raw materials for Oral Care.

Education and Training

Bachelors of Science in Chemistry, Fairleigh Dickinson University, Madison, NJ

Bachelors of Art in Political Science, Ramapo College, Mahwah, NJ

Villanova University - Six Sigma Green Belt

ASQ Certified Auditor

Publications:

Phenolic Antimicrobials, Part II 2,4-di-t-Butylphenol, A New Antibacterial Agent For Use In Oral Products

Compositions of Nisin with AHP Activator Technology for Broad Range Antibacterial Properties in Oral Compositions.

Effect of a Sanguinaria/Baking, Soda/Gantrez Rinse Compared to Viadent Rinse on Plaque In Vitro and In Vivo.

Development of The Magainin Peptide (MSI-469) as an Antiplaque/Antigingivitis Agent Using In Vivo & In Vitro Test Methods

The effect of a stain reducing agent, ALT-744 on chlorhexidine induced staining.

Professional Achievements

Patents:

#5723500 Antiplaque Oral Compositions and Method (Colgate Palmolive). - 1998

# 5681548 Oral Formula In Vitro Antiplaque Effects of Triclosan/Copolymer Mouth rinse

(Colgate Palmolive). – 1997

Awards

The Chair’s “You Can Make A Difference Award” Developing Triclosan Uptake Method and Sourcing Hydroxyapatite.

Team Spirit Award for significant contributions in launching Sensodyne.

Team Spirit Award for significant contributions in launching Aquafresh in Japan.

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