SUMMARY:

Pharmaceutical Quality Assurance and Compliance surrounding Solid, Sterile Parenteral and Liquid Injectable dose products while effectively supporting FDA 21CFR parts 3, 11,111, 210,211,820 and 503b regulations along with ISO 9001,13485, and ICH guidelines.

PROFESSIONAL EXPERIENCE:

Confidential, Boothwyn, PA

Sr. Director /Head of GMP Quality Compliance

Responsibilities:

• Ensured cGMP site compliance of policies and procedures throughout the organization for the manufacture of aseptic liquid for injectable and parenteral products while providing in - process decision making.
• Enforced compliancy of Site Policy, Quality Agreements, Confidentiality Disclosure Agreements, and approved Technical Reports, Analytical Test Methods, conducted Product Process Validation investigations and Product Batch Record disposition status.
• Responsible for remediating product complaints, Quality Systems, SOP’s and monitored performance efficiency to Change Control, Deviation/CAPA, and Document management.
• Integrated 21 CFR 210/211 and ISO 13485 guidance into 503b facility through product lifecycles including USP/GMP Analytical and Microbiology labs while upholding all applicable Quality and Regulatory and State Agency guidance.
• Executed cGMP audits of facility and supplier vendors for adherence to regulatory (FDA, DEA) expectations.
• Primary Sr. Management contact for FDA and customer inspection audits. Ensured company is continually in a state of cGMP inspection readiness by driving accountability of all applicable cGMP regulations across departments.
• Inspection Readiness program resulted in first 503b to pass an FDA Inspection with no observations.

Confidential, Madison, WI

Pharmaceutical QA Engineer Specialist (Consultant)

Responsibilities:

• Quality Process Improvement projects within Quality Operations, Validations and Regulatory Compliance for drug substance and antibody drug conjugate (ADC) compounds manufacturer.
• Lead remediation of quality preparation functions to investigate and resolve all CAPA and OOS issues including regulatory inspection preparedness ensuring satisfactory compliancy with FDA, EU, and ICH and GAMP 5 model.
• Quality review and approval of Project Risk Assessments, Equipment and Process Validation /IQ/OQ/PQ reports.
• Executed Equipment Validation Process Reports and High-Level Risk Assessments.
• Drove Interstate Manufacturing and Distribution License application process for Regulatory Affairs.

Confidential, Peachtree City, GA

Pharmaceutical QA Project Manager (Consultant)

Responsibilities:

• Managed QA project teams integrating sterile liquid syringe pharmaceutical products into combination kits for newly created CMO division providing cGMP compliance in handing, manufacturing, filling and packaging combination drug products for Phase III trials aligned with ISO 9001 and 13485, EU, ICH and FDA 21 CFR 3,4, 11, 210, 211 and 820.
• Authored cGMP documents, SOP’s supporting all quality related functionality for In-Process Controls for aseptic manufacturing starting with API product handling, storage, production, QC expectations, Batch Record and introduction of Design History file for assembly of medical device components.
• Overseen validations of equipment, Facility qualification and Serialization strategies.
• Created transitional synergy removing “silo effect” between Europe and US creating standardized cGMP practices with plastic injection molded medical device component manufacturer culture.

Confidential, Philla, PA

Quality Assurance Manager

Responsibilities:

• Managed 2nd shift QA departmental operations of GMP manufacturing, filling and packaging lines for solid dosage pharmaceutical products under EU, ICH and FDA 21 CFR. 210/211 and 11 guidelines.
• Authored, reviewed and approved GMP documentation; SOP’s, Batch Records, Investigations, Validation deliverables FMEA’s, Risk Assessments,
• Managed Quality System Change Control / CAPA program along with performance indicators/metrics/KPI’s, AQL sampling for inspection and Stability program activities and managed APR Quality review of commercial products.
• Assessed quality impact of product using statistical analysis tools due to nonconformance specifications.

Confidential, Eatonton, NJ

Quality Assurance Consultant

Responsibilities:

• Investigated unresolved non-conformance manufacturing issues and CAPA’s identified in FDA 483 audit involving API’s used in solid dosage batch campaigns.
• Re-evaluated product disposition status, determined “root cause” evaluating impact of deviation on final product disposition and identifying risk to previous product lots using statistical tools.
• Identified trends within deviations/investigations causing excursions interfering with product disposition.
• Drafted SOPs, Protocols, Technical and Equipment Validation/Qualification reports and associated deliverables.
• Reviewed all Microbiology / Analytical Laboratory reports, Environmental Monitoring data and assessed final QA Batch Record approval.

Confidential, Ft. Washington, PA

Quality Assurance FDA Consultant

Responsibilities:

• Initiated compliance improvements to Validation Master Plans identified as not aligning with regulatory expectations under EU, FDA 21 CFR parts 11, 210/211 and GAMP model.
• Incorporated quality driven rationale to develop Validation and IQ/OQ and PQ qualification deliverables.
• Applied risk management principles in data analysis, decision-making and reporting processes.
• Assured all investigations completed and corrective actions documented implemented and trends monitored.

Confidential, Cambridge, MA

QA FDA 483 Consultant

Responsibilities:

• Senior contributor to FDA 483 Consent Decree Audit Remediation multi-site project recommending improvements ensuring departmental compliancy with company standards against regulatory committee’s expectations.
• Reviewed GMP documentation (batch records. laboratory/manufacturing investigations, deviations, complaint investigations, environmental monitoring data, and test records) to support product release for finished drug product.
• Evaluated aseptic Class 100 sterility activities and reviewed microbiological excursion complaint investigations associated with bacterial and non-viable particle contamination.

Confidential, Basking Ridge, NJ

Quality Engineer

Responsibilities:

• Managed CSV lifecycle documentation, including Validation/Qualification Plans, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, System, Validation Reports, SOPs, Change Control Documentation, and Risk Assessment Reports
• Supported enterprise CSV related initiatives and remediation activities including FDA 21 CFR Part 11, 210, 211, & 820 and EU Annex 11 compliance.

Confidential, Memphis TN

Director Quality Assurance

Responsibilities:

• QA management and facility operational compliance oversight for Phase III sterile liquid and cellular biological products adhering to 21 CFR Parts 210, 211, 1270, 1271, ICH and ISO regulations.
• Reviewed and approved final batch records, investigated manufacturing deviations and laboratory non- conformances to evaluate product disposition by determining “Root Cause”.
• Improved In- Process controls for raw material sampling/ testing, Change management /CAPA program, component release and final product testing.
• Responsible for maintaining aseptic (ISO 5) manufacturing areas, monitor predetermined CFU limits are achieved and take immediate actions to remediate any particulate and microbial excursions and identify the root cause.

Confidential, Norcross, GA

Quality Specialist

Responsibilities:

• Project Manager Quality Compliance for sterile liquid reagents for Medical Diagnostic Device Company.
• Developed sterile/ liquid manufacturing process SOP’s and laboratory methodologies improving the GMP and GLP compliancy level to 21 CFR parts 210, 211, 11 and ISO 13845 standards.

Confidential, Frazer, PA

GMP Quality Compliance Manager

Responsibilities:

• Responsible for Quality Compliance assessment of risk in manufacturing processes, equipment, utility and facility qualification surrounding Solid, and Sterile Liquid product, identifying non-conformance practices, providing improvements to ensure company state of regulatory inspection readiness complying with EU, ICH, FDA 21 CFR 201/211 and 11.
• Liaison to cross functional departments taking responsibility in facilitating, auditing and maintaining key cGMP programs providing SME project oversight to compliance related activities and other specialized Quality related projects.
• Successfully developed departmental relationships providing cGMP and GAMP guidance improving validation IQ/OQ/PQ execution effectiveness.
• Responsible for developing improved Equipment, Utilities, and Computer System Validation and Qualification Policies and championed to in corporate “Quality by Design” into the Validation Protocol execution activities.
• Corporate Compliance Remediation team leading specific projects to remediate FDA Consent Decree observations at multiple sites developed a contingency plan creating a retrospective strategy and spearheaded new Inspection Readiness Plan initiative.

Confidential, Cherry Hill, NJ

Quality Assurance Operations Sr. Supervisor / Asst. Manager

Responsibilities:

• Supervised QA teams during sterile manufacturing in-process activities, release of raw material, and AQL sampling for component inspection, laboratory and stability studies
• Reviewed and approved Batch Records, Microbiology / Analytical lab reports, and environmental monitoring data.
• Maintained Change Management/CAPA program and departmental metrics and KPI initiatives.
• Accomplished in executing Manufacturing, Environmental, Equipment and sterility investigations to identify “Root Cause” determining product disposition and maintaining aseptic in ISO 5 manufacturing and filling.
• Developed GMP Training and Continuous Improvement programs leading to reduced excursions and atypical events.
• Authored Quality Policies and SOPs, improved internal and vendor audit programs and provided pivotal guidance in developing Equipment and Cleaning Validation protocols and reports.
• Participated in semi-annual media fill sterility/non-viable particulate challenge program.
• Project Manager executing remediation activities associated with FDA 483 observations.