Philip M. Padalino
Whitehall
Summary
Detail-oriented Compliance Specialist with extensive experience in regulatory compliance and risk assessment. Expertise in analytical methods to identify and mitigate compliance issues, ensuring adherence to industry standards. Proven track record of developing training programs that enhance employee development and foster an inclusive learning culture.
Overview
11
11
years of professional experience
Work History
Sr. QA Compliance Specialist
Genus Lifesciences, Inc.
05.2025 - Current
- Enhanced quality metrics reporting by tracking key performance indicators effectively.
- Streamlined processes through collaboration with cross-functional teams, ensuring regulatory compliance.
- Identified policy improvement areas through regular evaluations and recommended necessary revisions.
- Presented comprehensive company metrics for quarterly quality systems reporting effectively.
- Contributed to Change Controls and Continuous Improvement projects as a project team member.
- Conducted audits to pinpoint compliance gaps and proposed corrective actions.
Compliance Specialist
Genus Lifesciences
06.2020 - 05.2025
- Served as a point of contact for employees seeking guidance on compliance matters, instilling confidence in the organization''s commitment to regulatory adherence.
- Performed New Hire cGMP orientations and Annual cGMP presentations for the company.
- Considered the Subject Matter Expert (SME) with training/remediation activities for facility.
- Analyzed compliance data to assess trends, providing strategic recommendations for continuous improvement efforts.
QA GMP Trainer
Genus Lifesciences, Inc.
02.2018 - 06.2020
- Developed and implemented comprehensive training program across the company.
- Contributed significantly to Environmental Monitoring Program sampling responsibilities.
- Conducted New Hire cGMP orientations and annual cGMP presentations company-wide.
- Recognized as Subject Matter Expert for training and remediation activities.
- Served as key member of site’s Environmental Health and Safety First Responders.
QA Associate Inspector
Genus Lifesciences, Inc.
04.2017 - 02.2018
- Performed hourly inspections on finished goods based on AQL demands.
- Effectively monitored GMP processes to ensure compliance to batch record requirements.
- Staged and issued labeling components for commercial products.
- Assisted in the 5S of Quality Assurance packaging component area(s).
QA Inspector/ Label Technician & Verification Associate
Sharp Packaging Solutions
03.2015 - 04.2017
- Ensured GMP compliance by inspecting documents, machinery, and finished products.
- Produced accurate labels and assembled batch records per company guidelines.
- Led 5S initiative, enhancing workplace organization and efficiency.
- Conducted regular inspections of serialized products and controlled substances.
Education
B.S. Ed. - Special Education Mentally/Physically Handicapped PreK-8
Kutztown University of Pennsylvania
Kutztown, PA03.2015
B.S. Ed. - Elementary Education K-6
Kutztown University of Pennsylvania
Kutztown, PA12.2012
Skills
- Compliance monitoring
- Auditing processes
- Internal auditing
- Investigation techniques
- Training design and delivery
- Corrective action plans
Accomplishments
ASQ, Certified Quality Improvement Associate (CQIA) (Issued December 3, 2016)
ASQ, Certified Quality Auditor (CQA) (Expired December 31, 2023)
Affiliations
- American Society for Quality (ASQ)
- GMP Publications Mailing List
- Phoenix Group of Kutztown University
Timeline
Sr. QA Compliance Specialist
Genus Lifesciences, Inc.
05.2025 - Current
Compliance Specialist
Genus Lifesciences
06.2020 - 05.2025
QA GMP Trainer
Genus Lifesciences, Inc.
02.2018 - 06.2020
QA Associate Inspector
Genus Lifesciences, Inc.
04.2017 - 02.2018
QA Inspector/ Label Technician & Verification Associate
Sharp Packaging Solutions
03.2015 - 04.2017
B.S. Ed. - Elementary Education K-6
Kutztown University of Pennsylvania
B.S. Ed. - Special Education Mentally/Physically Handicapped PreK-8
Kutztown University of Pennsylvania