Peter Ponterio
Lockport
Summary
Quality Systems leader with 15+ years of experience in pharmaceutical and medical device environments, specializing in eQMS governance, CAPA, deviation management, change control, and validation. Proven track record of driving process standardization, inspection readiness, and continuous improvement across regulated environments (FDA, ISO, ICH). Experienced in partnering with cross-functional stakeholders and IT to enhance digital quality systems, data integrity, and operational performance. Recognized for leading teams, improving compliance metrics, and implementing scalable quality system solutions.
Overview
20
20
years of professional experience
Work History
Manager Quality Engineer
bioMerieux
Lombard, IL
12.2018 - Current
- Management: Manager of five (5) employees presiding over the Deviation Management, Change Controls, Customer Complaints, Batch Record Review and Release, and Supplier Quality.
- Validation of Raw Materials / Finished Products / Process / Equipment / Packaging Components: QA review and approval for all validation protocols and studies performed at the site. Validations examples include; Irradiation dosage, autoclaves, raw material qualifications, manufacturing lines, SaaS.
- Deviation Management System: QA Review and approval for Quality Events and manufacturing waivers.
- Equipment Change and Instrument Calibration: QA review and approval for equipment and facility changes. QA Approval for all calibration updates and Out Of Tolerances.
- Audit: Prepare, conduct, summarize and follow up on internal site and supplier audits. Host external auditors to answer questions and ensure compliance with Regulatory, Corporate, and Customer requirements.
Sr. Quality Assurance Specialist
Fresenius Kabi
Melrose Park, IL
04.2016 - 11.2018
- Validation: QA review of Technology Transfer (TT) protocols for new drug product validations, product process qualifications, continued process verifications, thermal cycling studies, machinability studies and material compatibility studies. Supported cleaning validations, qualifications, & re-qualifications for new and existing formulations and equipment.
- Validation of Laboratory Methods (Chemistry & Microbiology): QA review of data for a variety of laboratory testing (Chemical - pH, particulate analysis, HPLC / UHPLC, GC, ICP-MS, AA, water determination. Microbiology – product sterility, pour plate / filtration bioburden, KTA or Gel-Clot endotoxin analysis, antimicrobial / preservative effectiveness testing, antibiotic potency assay). Review and approve laboratory protocols for the chemical and microbiological testing of raw materials, in-process solution, and finished product.
- Validation of Equipment: QA review and approve of protocols for Installation, Operational, and Performance Qualification (IQ/OQ/PQ) of laboratory instruments. Assess compliance of User Requirement Specifications (URS) and Design Specifications (DS). Evaluate temperature alarms for environmental material holding chambers.
- Non-Conformance Investigations (Deviation, OOS, OOT): Review laboratory, manufacturing, and validation non-conformances for regulatory (FDA, ICH) and company compliance. Approve or assist in the investigation summaries and any resulting corrective actions and effectiveness checks. Release product for public consumption once non-conformance has been properly assured of minor impact to product, process, and systems.
- Review and Audits: Provide QA review of regional and site-specific controlled documents such as: SOPs, product specifications, laboratory Methods of Analysis (MOAs), master batch records, risk assessments. Audit laboratories for testing and safety compliance.
Training Specialist
Fresenius Kabi
Melrose Park, IL
05.2011 - 04.2016
- Instructor led and One on One Training: Created, published, and instructed the following training materials: GMP Documentation, Powered Pallet Jack Safety, Basic Aseptic Behavior, FK Data and Calculations, and Pest Control. Also performed instructor led classes for Personal Accountability and Behavior, Qualified Trainer Orientation, FDA Regulatory Trends, and Principles of Lyophilization. Training was given to all employees at the facility including management. Largest class size was 35 people.
- New Hire Onboarding: Coordinate on-boarding process and training requirements with department heads. Revise onboarding training process to shorten length of initial training while still complying with regulatory requirements and company policies.
- Regulatory Compliance: Execute training audits on all employees. Carry out training gap assessments on employees to fix compliance deficiencies. Continually improve hands-on training checklists and modules with department heads.
Microbiology Scientist
APP (now Fresenius Kabi)
Melrose Park
08.2006 - 05.2011
- Environmental Sampling/Testing: Test facility water for microbial bioburden, endotoxin, total organic carbon & conductivity. Test air and surface samples for particulate and microbial bioburden. ISO 5 gown qualified.
- Investigation Writing: Investigate microbiology non-conformances within the manufacturing environment. Implement action plans for the correction and/or prevention of further microbe recoveries.
Education
Bachelors - BCMB (Biochemistry, Cellular, and Molecular Biology)
Drake University
Des Moines, IA12-2003
Skills
- Critical & Technical Thinking
- Troubleshooting / Problem Solving
- Validation of Laboratory Methods
- Controlled Document Audit
- Manufacturing Deviation Investigations
- Training & Curriculum Development
- Product / Process / Equipment Validation
- Public Speaking
- Business Communication
- Action Plans / CAPAs
- Product Release
- Laboratory OOS & OOT Investigations
Accomplishments
- ASQ Certified Quality Auditor
- Support the planning and prioritizing of recovery efforts post manufacturing site exposure to EF-1 tornado
- Member of the Lombard Supplier Steering Committee (SSC) for Materials, Services, Maintenance, and Calibrations
- Develop and maintain gold standard QE Evaluations for constancy and reliability
- Team member of company Communities of Practice (CoP) for harmonization and continuous improvement: Quality Engineering, QMS, Supplier Quality, CI/CAPA, Risk Assessment, Tulip
Affiliations
- American Society of Quality (ASQ)
- American Society of Mechanical Engineers (ASME)
External Accomplishments
- President Emeritus of Lockport Jr. Porters youth sports organization providing over 230 children the opportunity to participate in football or cheerleading.
- CPR/First Aid Certified. Obtained the rank of Eagle Scout from Boy Scouts of America.
Timeline
Manager Quality Engineer
bioMerieux
12.2018 - Current
Sr. Quality Assurance Specialist
Fresenius Kabi
04.2016 - 11.2018
Training Specialist
Fresenius Kabi
05.2011 - 04.2016
Microbiology Scientist
APP (now Fresenius Kabi)
08.2006 - 05.2011
Bachelors - BCMB (Biochemistry, Cellular, and Molecular Biology)
Drake University