Scott Pecor

Rockville, ***** MD 1-301-***-**** ad1njl@r.postjobfree.com

Summary

Results-oriented Quality Assurance Specialist with a proven track record in ensuring regulatory compliance and enhancing operational efficiency. Adept at conducting comprehensive employee training, implementing and maintaining Standard Operating Procedures (SOPs), and collaborating with cross-functional teams to design and execute quality control processes. Experienced in conducting thorough audits and inspections, with a keen eye for detail and a commitment to continuous improvement. Skilled in root cause analysis, problem-solving, and implementing preventive measures to eliminate quality deficiencies. Strong communication skills facilitate effective collaboration with stakeholders at all levels. Demonstrated expertise in risk management and proactive compliance monitoring. Seeking to leverage these skills to drive excellence and elevate quality standards in a dynamic professional environment.

Skills

Regulatory Compliance

Training and Development

SOP Adherence

Cross-Functional Collaboration

Audit and Inspection

Documentation and Reporting

Root Cause Analysis

Process Enhancement

Quality Control Execution

Attention to Detail

Problem-Solving

Risk Management

Communication Skills

Compliance Monitoring

Experience

QUALITY ASSURANCE SPECIALIST 05/2023 - 09/2023

Guidehouse - Bethesda, MD

Spearheaded quality assurance oversight for NIH's Compounding Pharmacy, ensuring adherence to regulatory compliance and standards.

Conducted comprehensive employee training sessions to uphold regulatory and USP directives, fostering a culture of operational excellence and compliance within the organization.

Ensured strict adherence to Standard Operating Procedures (SOPs) and operational compliance, aligning processes with applicable regulatory and USP directives.

Collaborated with cross-functional teams to design and implement robust quality control processes, resulting in elevated product quality and heightened customer satisfaction.

Conducted rigorous audits and inspections, identifying areas for improvement and implementing corrective actions to guarantee continuous regulatory compliance.

Prepared detailed reports and documentation, highlighting quality issues, corrective actions, and providing recommendations for process enhancements.

Championed continuous improvement initiatives by actively engaging in root cause analysis, leading to the implementation of preventive measures and the elimination of quality deficiencies.

MANUFACTURING ASSOCIATE III 10/2018 - 01/2021

IDT Biologika - Rockville, Md

Executed and monitored complex manufacturing processes in compliance with cGMP and SOPs, ensuring the production of high-quality biologics.

Demonstrated expertise in the setup, operation, and troubleshooting of state-of-the-art manufacturing equipment, contributing to the efficiency and reliability of production processes.

Collaborated with cross-functional teams to optimize manufacturing procedures, resulting in increased productivity and reduced processing time.

Implemented rigorous quality control measures, conducting in-process testing and inspections to guarantee product integrity and adherence to regulatory standards.

Played a key role in the scale-up of manufacturing processes, ensuring seamless transitions and maintaining product consistency throughout production phases.

Trained and mentored junior associates on manufacturing protocols, safety procedures, and best practices, contributing to a skilled and knowledgeable workforce.

Conducted thorough root cause analyses for deviations or non-conformances, implementing corrective and preventive actions to enhance process reliability and product quality.

Maintained accurate documentation of manufacturing activities, ensuring compliance with regulatory requirements and providing a comprehensive record for audits.

LEAD MANUFACTURING ASSOCIATE/ TRAINING SPECIALIST 05/2010 - 10/2017

GlaxoSmithKline Pharma GmbH - Rockville, MD

Led and supervised manufacturing operations, ensuring adherence to quality standards, production schedules, and regulatory requirements.

Developed and delivered comprehensive training programs for manufacturing personnel, enhancing their skills and knowledge on GMP (Good Manufacturing Practices) and safety protocols.

Collaborated with cross-functional teams to optimize manufacturing processes, resulting in increased efficiency and reduced production errors.

Conducted regular audits and inspections to assess compliance with GMP guidelines, identifying areas for improvement and implementing corrective actions.

Played a key role in the onboarding process for new manufacturing associates, facilitating training sessions and ensuring a smooth integration into the production team.

Maintained and updated standard operating procedures (SOPs) to reflect the latest industry regulations and best practices.

Actively participated in continuous improvement initiatives, conducting root cause analysis and implementing corrective and preventive actions to enhance manufacturing processes.

MANUFACTURING ASSOCIATE III 06/2008 - 05/2010

Baxter Healthcare Corporation - Beltsville, MD

• Executed and monitored complex manufacturing processes in accordance with standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) to ensure product quality and compliance.

• Played a key role in the production of medical devices by operating and maintaining manufacturing equipment, troubleshooting issues, and implementing corrective actions to minimize downtime.

• Collaborated with cross-functional teams to optimize manufacturing processes, resulting in increased efficiency and reduced production costs.

• Conducted in-process inspections and quality checks to verify adherence to specifications, identifying and addressing deviations to maintain product integrity.

• Participated in validation activities for equipment and processes, ensuring compliance with regulatory requirements and industry standards.

• Contributed to the development and revision of SOPs, batch records, and work instructions to reflect continuous process improvements and ensure compliance with regulatory guidelines.

• Supported investigations into non-conformances, deviations, and root cause analyses, implementing corrective and preventive actions to enhance product quality and prevent reoccurrence.

Education and Training

University of Maryland, Global Campus - MS in Management

University of Maryland College Park - BS in Biology, General

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