George T Lopac III
Director of Quality Assurance at ORCOSA Inc- Claim this Profile
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Bio
Christopher Butler
George reported to me at Able Labs in the Quality department. He was hired to organize and manage the complaints function for the company as well as set up a GMP training program. George has a very good background in complaint handling and refined and managed the program effectively at Able. He created an organized tracking system, performed complaint investigations, and handled customer communication. George is very good at working towards a root cause and engages the appropriate departments to determine this while always keeping quality in mind. George makes appropriate decisions on the information obtained and recommendations for improvements. George has a very pleasant personality and works with customers and other internal staff well to obtain results. George also set up a GMP training program from ground level and rolled it out to the company. George utilized his experience and researched advanced topics to create an effective training program for all employees. George also took initiatives to assist with focused investigations when needed and coordinate Quality oversight for the DEA function. His organizational skills and ability to identify compliance risks was valuable for the company and provided an environment of Quality oversight critical for success.
Eric Lin
I worked with George at Lannett Company Inc. George and I communicated a lot and worked together to have all the required documents in place, even we were at different departments. George is a well organized person. He has a very good knowledge in controlled substance regulations, and is very proficient in SOP training and document control. He always knows what he is doing and gets the job done in a timely manner. He is responsible and a person whom you can rely on.
Christopher Butler
George reported to me at Able Labs in the Quality department. He was hired to organize and manage the complaints function for the company as well as set up a GMP training program. George has a very good background in complaint handling and refined and managed the program effectively at Able. He created an organized tracking system, performed complaint investigations, and handled customer communication. George is very good at working towards a root cause and engages the appropriate departments to determine this while always keeping quality in mind. George makes appropriate decisions on the information obtained and recommendations for improvements. George has a very pleasant personality and works with customers and other internal staff well to obtain results. George also set up a GMP training program from ground level and rolled it out to the company. George utilized his experience and researched advanced topics to create an effective training program for all employees. George also took initiatives to assist with focused investigations when needed and coordinate Quality oversight for the DEA function. His organizational skills and ability to identify compliance risks was valuable for the company and provided an environment of Quality oversight critical for success.
Eric Lin
I worked with George at Lannett Company Inc. George and I communicated a lot and worked together to have all the required documents in place, even we were at different departments. George is a well organized person. He has a very good knowledge in controlled substance regulations, and is very proficient in SOP training and document control. He always knows what he is doing and gets the job done in a timely manner. He is responsible and a person whom you can rely on.
Christopher Butler
George reported to me at Able Labs in the Quality department. He was hired to organize and manage the complaints function for the company as well as set up a GMP training program. George has a very good background in complaint handling and refined and managed the program effectively at Able. He created an organized tracking system, performed complaint investigations, and handled customer communication. George is very good at working towards a root cause and engages the appropriate departments to determine this while always keeping quality in mind. George makes appropriate decisions on the information obtained and recommendations for improvements. George has a very pleasant personality and works with customers and other internal staff well to obtain results. George also set up a GMP training program from ground level and rolled it out to the company. George utilized his experience and researched advanced topics to create an effective training program for all employees. George also took initiatives to assist with focused investigations when needed and coordinate Quality oversight for the DEA function. His organizational skills and ability to identify compliance risks was valuable for the company and provided an environment of Quality oversight critical for success.
Eric Lin
I worked with George at Lannett Company Inc. George and I communicated a lot and worked together to have all the required documents in place, even we were at different departments. George is a well organized person. He has a very good knowledge in controlled substance regulations, and is very proficient in SOP training and document control. He always knows what he is doing and gets the job done in a timely manner. He is responsible and a person whom you can rely on.
Christopher Butler
George reported to me at Able Labs in the Quality department. He was hired to organize and manage the complaints function for the company as well as set up a GMP training program. George has a very good background in complaint handling and refined and managed the program effectively at Able. He created an organized tracking system, performed complaint investigations, and handled customer communication. George is very good at working towards a root cause and engages the appropriate departments to determine this while always keeping quality in mind. George makes appropriate decisions on the information obtained and recommendations for improvements. George has a very pleasant personality and works with customers and other internal staff well to obtain results. George also set up a GMP training program from ground level and rolled it out to the company. George utilized his experience and researched advanced topics to create an effective training program for all employees. George also took initiatives to assist with focused investigations when needed and coordinate Quality oversight for the DEA function. His organizational skills and ability to identify compliance risks was valuable for the company and provided an environment of Quality oversight critical for success.
Eric Lin
I worked with George at Lannett Company Inc. George and I communicated a lot and worked together to have all the required documents in place, even we were at different departments. George is a well organized person. He has a very good knowledge in controlled substance regulations, and is very proficient in SOP training and document control. He always knows what he is doing and gets the job done in a timely manner. He is responsible and a person whom you can rely on.
Credentials
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RABQSA Lead Auditor
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Experience
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ORCOSA Inc
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United States
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Biotechnology
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1 - 100 Employee
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Director of Quality Assurance
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Apr 2021 - Present
Defines and promotes a quality mindset across the entire company. Responsible for managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule. Hires analysts, managers and leads incident investigations, Establishes and maintains a quality system to ensure the company’s facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and regulatory standards. Defines and promotes a quality mindset across the entire company. Responsible for managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule. Hires analysts, managers and leads incident investigations, Establishes and maintains a quality system to ensure the company’s facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and regulatory standards.
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Concours Pharmaceuticals
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Ewing, NJ
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Director of Quality Assurance
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Sep 2018 - Apr 2021
Assures quality products and processes by establishing and enforcing quality standards; testing materials and product. Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers. Establishes raw material standards by studying manufacturing and engineering requirements; conferring and negotiating with suppliers; devising testing methods and procedures. Establishes product quality documentation system by writing and updating quality assurance procedures. Maintains product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with other members of management to develop new product and engineering designs and manufacturing and training methods. Contributes to team effort by accomplishing related results as needed.
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Bausch Health Companies Inc.
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Canada
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Training Specialist
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Oct 2017 - Sep 2018
Maintains the Learning Management System (LMS) with the assignment of Curriculums and trainings. Provides system support to other Training Coordinators within the site and region. Assists in the development of Individual Training Plans. Works closely with management to identify training needs and requirements, and implements technical and management development training programs to support business unit objectives. Designs and develops training materials; manages trainer certification and training effectiveness evaluation systems. Designs curricula and programs for designated departments and job classifications. Ensures that the required technical, developmental and regulatory training is implemented in order to achieve compliance, business objectives and development of employees. Establishes and manages the LMS to ensure employees including temporary and contracted personnel training records are current and in compliance. Develops and implements training initiatives, assess progress, and focuses on the continuous improvement of training materials, programs and processes. Effectively communicates the requirements for training and provides follow-up. Provides direct support for internal/regulatory audits and responses to those audits. Manages all activities of the Training Department including the tracking of training projects and initiatives. Develops new procedures and revises existing procedures as required. Designs and delivers training modules including presentations that effectively engage and communicate. Performs training of personnel as required (i.e. hands-on, Instructor-led, workshops, etc). Assesses training results and re-trains when necessary. Represents the Training Department on project teams, management meetings and internal/external forums. Develops and provides training metrics information as required.
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Catalent Pharma Solutions
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Lead Trainer
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Nov 2012 - Oct 2017
Responsible for the development, management and organization of the training function to assure that employees and managers are properly trained to perform their assigned duties, and that training systems are maintained to meet cGMP • Works closely with management to identify training needs and requirements, and implement technical and management development training programs to support business unit objectives. • Design and develop training materials; manage trainer certification and training effectiveness evaluation systems. • Ensure that the required technical, developmental and regulatory training i implemented in order to achieve compliance, business objectives and development of employees. • Review SOP’s, cGMP, product related technical information, protocols, etc. to ensure technical training materials developed are current and in compliance with regulatory agencies and Company procedures. • Establish and manage training documentation system(s) to ensure employees including temporary and contracted personnel training records are current and in compliance. • Keep abreast of training and equipment options and technology changes; provides proper consulting information to ensure training effectiveness. • Develop and implement training initiatives, assess progress, and focus on the continuous improvement on training materials, programs and processes. • Work with and evaluate the quality and effectiveness of employees who provide training. • Apply adult learning concepts to lead and participate in on-going training mechanisms (e.g. print, web, CD, audio, video, and distance). • Effectively communicate to all departments the requirements for training and provide follow-up. • Provide direct support for customer/regulatory audits and responses to those audits. • Oversee New Employee Orientation.
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Hemispherx BioPharma Inc.
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New Brunswick, NJ
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Quality Assurance Manager
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Mar 2010 - Nov 2012
Manage Corporate cGMP Training, Document Control, Internal / External Auditing, Regulatory Deliverables, Change Control. Implementing and maintaining Quality Systems, Deviations/CAPA, Training & Vendor Qualification. Manage Corporate cGMP Training, Document Control, Internal / External Auditing, Regulatory Deliverables, Change Control. Implementing and maintaining Quality Systems, Deviations/CAPA, Training & Vendor Qualification.
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Lannett Company, Inc.
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Manager, QA Compliance
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Jan 2007 - Jan 2010
Quality System management, corporate wide cGMP Training, Internal / External Audits, Investigations / CAPA, Change Control, Deviations, Manufacturing Investigations, OOS and Process / Systems Validation. Reported Quality metrics to management on monthly basis. Quality System management, corporate wide cGMP Training, Internal / External Audits, Investigations / CAPA, Change Control, Deviations, Manufacturing Investigations, OOS and Process / Systems Validation. Reported Quality metrics to management on monthly basis.
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Manager, QA Compliance
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Jul 2005 - Oct 2006
Managed Quality Systems: In-Process QA / Batch Record Review, Complaint Manager, CAPA Manager, Batch Record Review, Product Release, Systems Validation, Document Control, CFR Part 11, Validation, Stability Protocol Review and Internal/External audits. Company Wide cGMP Training * SOP Training * Safety Training * Maintain Training Database * Report Training Metrics Managed Quality Systems: In-Process QA / Batch Record Review, Complaint Manager, CAPA Manager, Batch Record Review, Product Release, Systems Validation, Document Control, CFR Part 11, Validation, Stability Protocol Review and Internal/External audits. Company Wide cGMP Training * SOP Training * Safety Training * Maintain Training Database * Report Training Metrics
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QA/DEA Compliance Specialist / Corporate Trainer
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Sep 2002 - Jun 2005
GMP Corporate Trainer - Designed and administered cGMP Training for all employees DEA Supervisor in charge of the following functions with a staff of 3 employees Quota requests, ARCOS Reports, Year-End Inventory, Weekly Cycle Counts, Security, DEA 222 Forms, Off-site CS Destruction, 3RD Party CS Destruction, Vault / Cage Access, Product Reconciliation, DEA Training, Report Metrics Monthly Product Complaints, Med-Watch Reporting, Document Control, Change Control and Deviations/CAPA.
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Senior QA Complaint Specialist
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Jan 1985 - Nov 2001
Key member of the Customer Quality Assurance Team, Responsible for customer complaints, Coordinate, prepare and administer procedures to ensure Global and J&J compliance Company SOPs Departmental Procedures, Alert Notifications, MDR Reporting, Customer Letters, Adverse Experience Reporting, Maintain Employee Records, Employee Training, Failure Investigations, Software Validation, FDA Audits Key member of the Customer Quality Assurance Team, Responsible for customer complaints, Coordinate, prepare and administer procedures to ensure Global and J&J compliance Company SOPs Departmental Procedures, Alert Notifications, MDR Reporting, Customer Letters, Adverse Experience Reporting, Maintain Employee Records, Employee Training, Failure Investigations, Software Validation, FDA Audits
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