Experience

On Demand Pharmaceuticals Inc
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Senior Quality Assurance Manager

  • Nov 2021 - Present

PluroGen Therapeutics, LLC
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Quality Assurance Manager

  • Apr 2020 - Nov 2021


Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Product Quality Specialist

  • Apr 2018 - Apr 2020

  • Effectively coordinates investigations, disposition of batches, review and approve all Master Batch Records, calibration records, Quality Agreements, and Annual Product Reviews. • Responsible for supporting internal, client, and regulatory audits through coordination and/or leadership of the audit backroom. • Primary quality liaison for clients and internal customers as subject matter expert for product, processes and requirements. • Interfaces with all other departments to ensure coordination and compliance with SOPs and cGMPs via observation of existing processes and implementation of continuous improvement initiatives. • Demonstrate extensive knowledge of quality, regulatory, and legal standards including EP, JP, GMP, ICH, DEA, and FDA, while successfully maintaining regulatory alignment internally, with client partnerships Show less



GSK consumer Health (Formerly Novartis)

• Quality Assurance Specialist

  • Jun 2012 - Nov 2017

  - Providing quality oversight at the shop floor level and systematic being able to identify, prioritizing, communicating, and resolving quality issues in accordance to regulatory guidance’s. - Working with manufacturing operations to solve in-house quality concerns, reviewing of nonconforming product and recommending disposition. Working with associates to identify and develop continuous improvement strategies that will drive operational excellence - Reviewing and approving standard operating procedures, batch records, design documents, deviations, CAPA’s, corrective actions, change controls, standard operating procedures, validation/ qualifications Protocols and reports. - Providing support with multiple business process systems to support all areas of manufacturing. - Facilitating and mentoring associates to provide solutions, to optimize resources while offering technical and compliance guidance through the manufacturing organization. - Providing quality control review of data to promote accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations. - Teaming up with Engineers, Technical Associates in the daily support of the Manufacturing Operations and resolution of any equipment-related process constraints and implementation of related projects. - Teaming with investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence in deviations in quality and Technical matters. Show less



CorePharma LLC

• United States
• Hospitals and Health Care

• Quality Assurance Operations Specialist

  • Aug 2011 - May 2012

  - Responsible for performing line clearance activities in manufacturing and packaging areas. These activities include; a) verification that all previous materials and/or products have been removed from the area b) all required cleaning has been completed by verification of entries in appropriate logs, and c) that equipment has been set up per SOP instruction and/or as directed in the batch record. - Collected samples and performed tests and inspection as directed by SOPs and Batch Records. - Identified relevant quality-related training needs and delivering training ensuring tests and procedures are properly understood, carried out and evaluated that product modifications are investigated if necessary. - Responsible for performing designated verifications assuring the processes are being performed as required by applicable written procedures (e.g. SOPs, batch record, protocols, etc.). - Responsible for the review of documents (e.g. batch records, log sheets, etc.) to verify that activities have been performed as required and where discrepancies are found immediately documenting issues and notifying the supervisors. - Responsible to collect and maintain test records for quality functions, assisting in the development and support with Quality processes, monitoring performance and gathering relevant data for statistical reports. Show less



Almac Clinical Technologies

• United Kingdom
• IT Services and IT Consulting
• 1 - 100 Employee

• Label ProjectCoordinator

  • Dec 2008 - Jun 2011

  • Facilitate the printing/reprinting and inspection of all study labels to meet packaging deadlines. • Communicated with customers to respond to questions pertaining to their studies • Act as Label Generation Support Representative by reviewing and approving validation protocols/tests before and after execution • Communicate with all necessary departments to ensure quality and protocol are met • Facilitate the printing/reprinting and inspection of all study labels to meet packaging deadlines. • Communicated with customers to respond to questions pertaining to their studies • Act as Label Generation Support Representative by reviewing and approving validation protocols/tests before and after execution • Communicate with all necessary departments to ensure quality and protocol are met



Catalent Pharmaceuticals

• 1 - 100 Employee

• Quality Assurance Auditor

  • May 2008 - Oct 2008

  Review batch records by identifying, communicating and obtaining any needed corrections during packaging process. Maintained batch record error matrix and investigation as required Provides ongoing training to staff on procedures including safety monitoring/reporting requirements, handling of biological specimens, drug management and data management activities Conducting audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMPs, DEA, Corporate and Pharmaceutical Development standard operating procedures. Performs QA Room releases, line clearances, equipment releases and AQL inspections as required. Audit of executed batch records for compliance with CGMP and provide customer audit responses as required. Audit of raw materials, facility logs, release data. Interdepartmental communication for obtaining information and audit corrections. Comply with and ensure compliance of the department with Health, Safety and Environmental responsibilities. Show less



Addeco

• United Kingdom
• Human Resources Services
• 1 - 100 Employee

• Site Manager

  • Apr 2007 - Jun 2007

  Receive, handle, and fill all client requests for services, in accordance with prescribed policies and procedures. Interview, hire, and train appropriate and qualified temporary staff to fill assignments. Coordinate needs analysis and the production of profiles for all job specification. Monitor available resources and skills in the Adecco organization to ensure appropriate employees are available to meet client current and pending staff needs. Ensure that all policies, procedures, and standards are adhered to with respect to quality assurance, timesheet reporting, approvals, performance improvement, and issues-escalation and resolution. Provide weekly and monthly reports to Operations Manager as per standard policies and procedures. Implement quality improvement initiatives as required. Show less



Christiana Family Dental Care

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Office Manager

  • Sep 2004 - Apr 2006

  Reviewed and made recommendations on insurance contracts and managed care organizations. Hired, trained and performed annual evaluations of office staff and clinical staff. Designed and implemented policies and procedures for Quality Management Program including data collection, case analysis methods, outcome performance measures, chart review procedures, and critical pathways analysis Designed and implemented information system flows for improved analysis of statistical and financial information and of technical reports. Analyzed financial reports based on productivity and the profitability of the practice in respect to future and current project. Responsible for management and overseeing compliance with OSHA, state and federal regulations Coordinated various departments, programs, services, and provides efficiency in the management of organization's resources. Show less



G.E. Energy

• Greece
• Renewables & Environment
• 1 - 100 Employee

• Production Supervisor

  • Oct 2000 - Jan 2005

  Module Line and Cell Line Supervisor. Proactively consulted with management regarding status of products in production, potential inventory shortfalls, and production schedules etc. Effectively hired, trained, evaluated, and supervised 35 to 70 hourly employees. Improved quality and efficiency through creative solutions and collaboration with engineers, employees, and management including product changes, line changes and training enhancements. Maintain excellent product quality through communication with engineers. Used statistical tools to effectively collect and analyze data and creative problem solving to develop process improvements, upgrades, work instructions and safety rules. Show less