Quality Assurance Control

Stanley D. Gratz

******@*******.***

**** **** **** **. (H): 215-***-****

Huntingdon Valley, PA 19006 (C): 267-***-****

Quality Assurance / Chemist

Extensive experience managing quality assurance in pharmaceutical manufacturing environments for industry leaders including McNeil. Demonstrated success in delivering improvements in testing procedures, creating SOPs and driving quality control processes to ensure compliance with FDA regulations. Experience in new facility set-up and quality management. Broad command of all types of production and QC laboratory equipment. Thoroughly trained in cGMP and FDA requirements. Broad product knowledge covering tablets, capsules, liquids sprays and gels. Exceptional analytical skills applied to driving optimal quality in manufacturing and production.

Throughout my many years of service to the pharmaceutical industry I have been involved with all types of change control and even wrote the Change Control SOP for all the companies in which I worked. I am also well advanced in the procedures in gathering, analyzing, reviewing information for change control and in the approval process. I am well versed in MS Work, MS Excel and statistical analysis programs. During my tenure at the companies in which I either managed or worked at, I gained knowledge in labeling and was responsible for labeling information and changes to meet FDA requirements.

• Quality Control • Product Formulations • cGMP and Change Control

• Regulatory Compliance • Laboratory SOPs • Validation Studies

• Manufacturing SOPs • Stability System 2008 • Wrote and Reviewed Module 3 of the CTD

• New Facility Set-Up • IQ/OQ/PQ • Quality Training

B.S., Chemistry (Minor – Pharmacy) – Philadelphia College of Pharmacy and Science.

A.S., QA/RA – Temple University College of Quality Assurance and Regulatory Affairs.

Career History

Quality Control Technical Writer-- Lannett Co .Inc (Philadelphia, PA), August 2014-August 2015. I was involved in the writing of SOP’s, Laboratory Qualification documents (IQ/OQ/PQ), and methods.

Quality Assurance – KVK-TECH, Inc (Newtown, PA), January 2010-November 2010. (Contract position)

Wrote SOP’s and Validation Protocols.

Performed qualification of manufacturing equipment.

Organized, wrote and reviewed Module 3 (Quality) of the CTD for various generic pharmaceuticals.

Quality Assurance / Chemist – Cetylite Industries, Inc., December 1993 – December 2009. Supervised QC and QA departments in this pharmaceutical and medical device manufacturing company. Purchased new QC lab equipment and trained personnel in their use including: HPLCs, FTIR, UV, GCMS, Karl-Fisher and all other lab equipment related to testing and release of both raw and finished products. Developed and performed all IQ/OQ/PQ operations on both the laboratory equipment and the manufacturing equipment. Developed and performed all types of validation procedures for finished dosage forms and the D.I. Water system including all cleaning validations for the manufacturing equipment.

• Implemented use of new formulation and packaging rooms to remediate fifteen 483

observations from the FDA. Developed and wrote all new SOPs along with designing new

rooms, purchasing new equipment and creating proper flow to meet cGMP requirements. FDA

had issued no observations in both QC and manufacturing subsequent to the improvements.

• Purchased and operated new comprehensive stability study system using Stability System 2008

to replace my own stability program developed in MS Access.

• Instituted a new SOP system and wrote all SOPs for all departments in the company. Drew

upon extensive previous experience in writing and implementing SOPs and procedures for both

QA/QC and production departments.

Stanley D. Gratz Page 2

Quality Assurance / Chemist – JWS Delavau, February 1992 – Octerber 1993. Worked with QC and QA departments in testing pharmaceutical tablets and revamping their SOPs and laboratories. Performed all types of testing on in-process and finished tablet production including dissolution, friability, tap density, hardness and assay. Responsible for all aspects of daily quality assurance operations including writing SOPs, inspections, complaints, outside contractors, customers, FDA inspections and all other related operations.

• Formalized procedures in formulation and production to align with FDA quality standards.

Corrected deficiencies in cGMP requirements and poor production procedures. Brought

manufacturing and formulation operations into compliance with FDA regulations. Re-wrote

SOPs and assisted in training personnel in cGMPs and other FDA requirements.

• Purchased and validated a new D.I. Water system for finished dosage forms.

Quality Control Chemist – McNeil CPC, March 1991 – January 1992. Responsible for testing of both raw materials and finished products. Performed all types of testing on many products including Tylenol PM, including HPLC analysis and GC Headspace analysis. Tested bulk granulations including tap density and sieve analysis. Tested finished tablets for friability and dissolution.

• Developed new analysis method using less solvents for HPLC analysis of Tylenol PM,

reducing solvent volume by 50%. Modified and ran a validation on HPLC method with

comparative validation against old method.

• Improved assay method for Tylenol PM which decreased time and solvent requirements for the

assay.

Quality Control Director / Chemist – Lannett Co., Inc. 1975 – 1991. Served as a chemist and Quality Control Director for this generic pharmaceutical manufacturer of tablets, capsules, liquids and ointments.

• Worked in both production and formulations of all types of tablets and capsules. Developed

and improved ease of production along with dissolution, quality and stability. Extensive

experience with formulation ingredients required for tablet and capsule production.

• Purchased Lannett’s first HPLC in 1976, attaining expert proficiency in HPLC. Adept at

managing HPLC method development, validation, stability method development and improving

older methods for speed and separation and maintenance. Developed several methods currently

in use by USP.

• Performed all types of testing on in-process and finished tablet production including

dissolution, friability, tap density, hardness and assay.

• Purchased all new QC lab equipment and trained personnel in HPLCs, FTIR, UV, GCMS,

Karl-Fisher and all other lab equipment related to the testing and release of both raw and

finished products.

• Developed and performed al IQ/OQ/PQ operations on both the laboratory equipment and

manufacturing equipment.

• As Director of Quality Assurance, responsible for all aspects of daily operations including

writing SOPs, inspections, complaints, outside contractors, customers and FDA inspections.

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