Director, Quality Assurance and Compliance

• Jun 2022 - Present

Senior Manager, Quality Assurance

• Sep 2013 - Present

• Responsible for all quality systems for label manufacturer of clinical trials and investigational drug products.• Responsible for a staff of 34 individuals, including Managers, QA Specialists and Supervisors. • Develop, write, revise and approve all SOPs.• Solely responsible for customer audits, including audit responses. • Instituted company-wide calibration program, effectiveness training, mock recalls, AQL statistical sampling plans, line clearance methods and specifications for components.• Developed code system for customer complaints, investigations, utilized in trending analysis. • Developed training matrices for all employees.• Responsible for cGMP and SOP training programs.• Write and execute validation protocols - Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification on various equipment.• Complete customer Quality Agreements, Technical Agreements and questionnaires. • Revised and enhanced preventative maintenance program, ensuring overall compliance.• Maintain Safety Data Sheet (SDS) manuals, facility pest control and emergency lighting programs.

Senior Manager, Quality Assurance

• Sep 2013 - Present

Director, Quality Assurance

• Nov 1998 - Sep 2013

Responsible for all quality systems for commercial production of OTC and homeopathic products Develop, write and approve SOP's, packaging component specifications Solely responsible for implementing and securing ISO 13485:2003 and ISO 9001:2000 certifications Verify all calculations and approve all work documented in chemistry notebooks Initiate, write, implement process validations, including purified water system Liaison / contact for outside vendors; perform vendor audits Review and approve all Master Batch Records, Master Packaging Records Authorize final disposition for all raw material, packaging components, WIP, and finished products Supervise and train QA inspectors Review, proofread and approve all labeling, including promotional advertising literature Established, implemented and maintain all control documentation records Perform statistical analysis on test data, including Annual Product Reviews Responsible for Change Control, customer complaints Stage all stability samples, with pertinent test intervals Oversee maintenance of Material Safety Data Sheet (MSDS) files Manage and coordinate hazardous waste pick-up and disposal Additional responsibilities include sampling and testing of components and purified water system

Quality Assurance Manager

• Jan 1995 - Apr 1998

Instrumental in designing, preparing and implementing all Quality Assurance Systems from Start-Up mode to commercial production of Rx/OTC pharmaceutical creams, lotions ointments and medicated shampoos Developed and wrote SOP's, components test methods and packaging specifications Supervised and trained three QA inspectors and one Label Room Coordinator involved in QA activities including incoming sampling, in-process packaging line inspection, cleaning validation sampling and labeling control Authorized final disposition for all raw materials, packaging components and finished products Assisted Regulatory Affairs in Drug Registration for foreign countries Responsible for customer complaints, Adverse Drug Reaction Reports and Change Control Reviewed and approved all Master Batch Records, Master Packaging Records, including R&D pilot batches Developed, implemented and maintained all control documentation records Established and maintained Label Room, including Installation Qualification (IQ) and Performance Qualification (PQ) of Label Counting Machine Responsible for Customer Complaints, Adverse Drug Reaction (ADR) Reports and Change Control Developed and approved Rx and OTC label copy Reviewed, approved and executed Cleaning Validation Protocols for manufacturing and packaging equipment

Manager of Quality Assurance and Regulatory Affairs

• Jan 1991 - Apr 1993

Responsible for Medical Device Listing; Assisted in 510(k) submissions to the FDA Responsible for Change Control, Customer Complaints; Maintained all records pertaining to Quality Assurance Initiated OEM program, company wide Supervised two Quality Assurance personnel and four QC inspectors Wrote, participated in, reviewed and approved Process Validation Protocols, QC/QA test, inspection and systems procedures Reviewed and approved all Batch Records, labeling material Coordinated and monitored product recalls/product notification

Quality Control Manager/Operations Manager

• Jan 1981 - Jan 1991

This unique position had dual responsibilities: Oversaw total quality manufacturing process from raw material to final product Full interfacing with production personnel and manufacturing lines; Supervised seven quality control inspectors three direct and two indirect labor forces; reported monthly variances Maintained all records pertaining to QC and controlled plate making and printing of over 10,000 different product codes Assigned disposition to all raw material components and finished goods Direct contact with vendors and FDA inspectors Prepared and responsible for yearly departmental budgets in excess of $500,000 Established bar code methods, techniques and application for all final products, which resulted in both internal and external customer satisfaction Recommended and implemented computerized labeling systems, for a $40,00 investment, resulted in a cost savings in excess of $250,000 Wrote manufacturing SOP's for three domestic plants and one off-shore facility

Quality Assurance Specialist

• Jan 1981 - Apr 1990

Named Acting Quality Control Manager

• Feb 1982 - May 1982

Established label control system; Wrote inspection and test proceduresSupervised 14 quality control inspectorsAssisted Regulatory Affairs in writing Device Master Records; Full knowledge and application of Military Standards