Quality Control Management

Marc E. Joseph

**** ********* ****** **** *** t Champions Gate, FL 33896

443-***-**** t *********@*****.***

Quality Control/Quality Assurance Manager

A Recognized Expert in Quality Control

Experienced in all aspects of Service Delivery

A highly efficient, methodical and talented Quality Control Chemist with over 14 years experience developing and implementing effective quality control, quality assurance, manufacturing, validation, compliance and regulatory processes in a pharmaceutical manufacturing environment. Strong experience with various manufacturing processes, documentation systems, SOP’s, cGMP, GLP, as well as NDA/ANDA (CMC Section) preparations and reviews and FDA regulations. Effective communicator with excellent relationship management skills, a results oriented attitude and analytical skills.

CORE COMPETENCIES

Quality Management t Quality Control t Quality Assurance t Program Management

Team Management t Audits t Quality Reviews t Operational Effectiveness t Leadership

Problem Resolution t Business Development t Service Delivery t Communication

Staff Recruitment and Training t Compliance/Regulatory Processes t Vendor Management

t CAPA t Root Cause Analysis

EXPERIENCES AND ACHIEVEMENTS

NEPHRON PHARMACEUTICALS CORP., Orlando, FL 10/2015 – Present

A privately owned manufacturer of generic inhalation solutions headquartered in Orlando, FL that specializes in Blow-Fill-Seal Manufacturing (allowing vials of medication to be formed and sealed in a continuous process without human intervention in a sterile, enclosed area.

Stability Manager 1/2016 - Present

Analyze and manage the distribution of samples for testing at designated time points. Prepare the Stability Protocols and the Reports. Initiates the selection of products for stability studies and the review of stability data. Responsible for the upkeep of the stability chambers including verification and monitoring of the charts/alarm systems for all chambers.

tAssure stability data is reviewed; products selected for testing, write stability protocols, prepare stability reports, upkeep of stability chambers and verify chamber charts

Chemistry/Quality Investigator 10/2015 – 1/2016

Conducts QC and R&D chemistry laboratory investigation in accordance with approved analytical methods, SOPs and/or protocols consistently following laboratory GDP and cGMP requirements.

Performs Phase II Out of Specification (OOS) investigations. Performs quality review and approval of documents, data, protocols and/or reports. Maintains quality databases and may perform analysis and trending in support of site metrics.

tLeads Root Cause Analysis for Laboratory Investigations.

tProvides training in quality and compliance topics in areas of expertise.

tProvides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed.

tWorks with the quality and other departmental stake holders as an investigation leader.

BIORELIANCE, Rockville, MD 3/2015 – 9/2015

The company provides nonclinical testing and manufacturing services for biologics.

Quality Control Supervisor

Oversees the development, implementation and maintenance of quality control systems and activities. Coordinates documentation of laboratory deviations, incidents and investigations. Reviews and revises analytical methods, SOPs, equipment IQ/OQ/PQ, and investigation reports. Hire, train, and supervise all employees.

tEnsure regulatory compliance, develop standard operating procedures and train personnel in the use of pharmaceutical technological methods using analytical instrumentation.

tInteract with regulatory agencies to present applicable data, explain incidents, trends and reports as needed.

EMERGENT BIOSOLUTIONS, Baltimore, MD 10/2006 – 9/2014

The company, formerly Cangene BioPharma, is a multinational specialty biopharmaceutical company.

Quality Control Analytical Services Supervisor 8/2008 – 9/2014

Documented and reviewed SOPs, specifications, testing methods, raw material specifications and stability data review of new and existing products. Initiated OOS investigations for Final Product, In-Process, Stability or other cGMP data and troubleshooting of manufacturing and packaging deviations as well as execution of process validation.

tLead team in 5S method of LEAN manufacturing to reduce waste, shorten cycle times, develop process standardizing, and expedite ability to rapidly respond to customer requirements.

tReviewed and approved quality-related documents, including but not limited to: protocols; qualification, validation and stability reports; test results, including raw data; calibration certificates; temperature charts; and environmental monitoring data (WFI and temperature controlled charts).

tSupported department compliance and productivity goals, often exceeding Service Level Agreements.

Quality Control Chemist III 5/2008 – 8/2008

Conducted routine analysis of raw material, according to approved SOPs using Analytical Measurement Techniques. Documented test results, problems and other relevant information under cGMP. Performed instrumental analysis such as HPLC, Gas Chromatography, and Ion Chromatography. Supervised and mentored laboratory staff.

tDeveloped and performed simple revisions and updates to SOPs as necessary.

tConducted instrumental analysis such as Chromatography, Spectroscopy, pH, TOC, Osmometer.

Quality Control Chemist II 10/2006 – 5/2008

Conducted Analytical Services testing including inventory control and database updates. Performed WFI sampling and testing as per current protocol, or validation protocols to support the WFI system. Performed initial qualification, calibration and troubleshooting of issues, which arise during routine analysis.

tSample in-coming and in-use raw materials routinely, and keep record of anticipated changes in the production.

tFollowed governing compendia’s (USP/NF, FCC, EP/BP, JP)

GLAXOSMITHKLINE, Clifton, NJ 12/2001 – 10/2006

The company is a British multinational pharmaceutical company and the sixth largest pharmaceutical company in the world in 2014.

Chemist

Conduct routine analysis of over 100 raw materials, according to approved SOPs using Analytical Measurement Techniques including HPLC, IC, pH Systems, Densitometer, Viscosity meter, Melting Point, UV/Vis, and Wet chemistry tests in compliance with USP/NF, FCC, and Japanese regulations.

Initiated Technical Change Control applications as needed.

t5S Leader in “Batches Right First Time” Project for Aquafresh Extreme Clean Toothpaste

EDUCATION

Bachelor of Science, Chemistry, East Stroudsburg University, East Stroudsburg, PA, 1998

Associate of Applied Science, Chemical Technology, County College of Morris, Randolph, NJ, 1995

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