Marc Joseph

A highly efficient, methodical, and talented Quality Assurance and Quality Control Analyst with over 25 years of experience developingand implementing effective quality control, quality assurance, manufacturing, validation, compliance, and regulatory processes in a manufacturing environment. Strong experience with various techniques, instrumentation, processes, documentation systems, SOP’s, cGMP, GLP, and FDA regulations. Effective communicator with excellent relationship management skills, a results-oriented attitude, and analytical skills.

FORMULATED SOLUTIONS, Largo, FL 03/2023 – 08/2023

Quality Control Laboratory Supervisor

Lead and assist in the daily activities within the lab. Responsible for ensuring the team is reviewing the completeness, accuracy and cGMP compliance of the data and documentation generated in the Quality Control Laboratory. Strong knowledge of analytical testing in a cGMP Quality Laboratory. Maintain a level of technical knowledge and understanding of Analytical testing consistent with current scientific literature.  Plan daily technical activities to meet established timelines. Provide input to establish project timelines.  Ensure testing is performed accurately and in compliance with GLP, GMP, USP, EP, SOP’s and other approved test methods.

TRULIEVE, Tampa, FL 04/2021 – 03/2023

Quality Assurance Assistant Manager

Managing the quality department with responsibility for total product / package quality, cost management, safety, compliance, GMP’s, and executing all QA protocols to ensure Plant Quality service objectives are met. Evaluate production environments to make sure conditions meet safety codes and advise responsible parties when these standards are not met.  Assist in overseeing the entire production process to ensure quality control at every stage.  Responsible for ensuring that Cannabis products in production (Edibles) meet the safety and specification standards necessary for them to be forwarded to the last production stage before reaching Dispensary Stores.

WORLD PRODUCT SOLUTIONS, St. Petersburg, FL 11/2019 – 04/2021

Coordinates day to day operations for all quality activities within two facilities (Manufacturing and Fulfillment). Review all process and facility documentation and records.  Ensure the site follows cGMP guidelines, adherence to policies and standards across the area of focus. Partnership with other functional areas – Product Development, Operations, Customer Service, Quality Control, etc. to ensure continued compliance for the area/site.  Ensure Quality systems are compliant with corporate and site procedures as well as industry standards for systems such as Complaints, Investigations, Batch Record Review, Root Cause Analysis, Corrective and Preventative Actions, Training, Deviations, and Change Controls.

CELMARK INTERNATIONAL INC., Orlando, FL 6/2016 – 11/2019

Quality Control Laboratory Supervisor  11/2018 – 11/2019

Coordinates all activity within the Laboratory – releasing Raw Materials, Bulk Product, and Finished Product.  Create Raw Material Evaluations for all Raw Materials received.  Create Master Manufacturing Record documents for all formulas manufactured.  Develop and maintain finished product and raw material specifications.  Assist with Finished Ingredient Listing and Quantitative Ingredient Listing for new products created within the company.

Regulatory Coordinator  6/2016 – 11/2018

Responsible for the design, drafting, coordination, review, maintenance, and submission of regulatory documentation for both internal and external use. Work with the necessary departments to identify, address, eliminate and prevent discrepancies. Review finished product labeling to ensure accuracy, completeness, and regulatory compliance. Serve as a subject matter expert and coordinate label activities related to products. Perform regular inspections and accountability for labels. Create and review product specification data for products. Create SDS Sheets for all products.  Develop Finished Ingredient Listing (INCI listing) and Quantitative Ingredient Listing for new products created within the company.  Work with Quality Operations on the development and institution of regulatory practices and documentation which are required for compliance.  Create Master Manufacturing Record documents for all formulas manufactured.

NEPHRON PHARMACEUTICALS CORP., Orlando, FL 10/2015 – 6/2016

Stability Manager  1/2016 – 6/2016

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.  Assure 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, SOP’s 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.Leads Root Cause Analysis for Laboratory Investigations.Provides training in quality and compliance topics in areas of expertise.  Provides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed.

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

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, SOP's, equipment IQ/OQ/PQ, and investigation reports. Hire, train, and supervise all employees. Ensure regulatory compliance, develop standard operating procedures, and train personnel in the use of pharmaceutical technological methods using analytical instrumentation.Interact with regulatory agencies to present applicable data, explain incidents, trends and reports as needed.

EMERGENT BIOSOLUTIONS, Baltimore, MD 8/2008 – 9/2014

Quality Control Analytical Services Supervisor

Documented and reviewed SOP's, 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. Lead team in 5S method of LEAN manufacturing to reduce waste, shorten cycle times, develop process standardization, and expedite ability to rapidly respond to customer requirements.  Reviewed 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.

Bachelor of Science, Chemistry, East Stroudsburg University, East Stroudsburg, PA, 1998
Associate of Applied Science, Chemical Technology, County College of Morris, Randolph, NJ, 1995