Deborah Townsend Email & Phone Number

Philadelphia, Pa, Us

Fort Washington Pa

Responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Support areas include Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits, In-Process Testing/AQL, and APR. Interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance as it relates to site Quality Assurance responsibilities.

Spring House, Pa

Support and prepare to transfer the quality control department supporting the phase I/II clinical manufacturing plant from USA to Ireland. Maintain work assignment schedules and review for timely release of raw materials, in-process testing, cleaning verification, and bulk product release in order to ensure uninterrupted clinical trial drug supply. Write, revise, and review SOPs and specification documents. Schedule and review of stability lot testing.• Authored utilities, compressed air and gas trending reports to meet compliance standards and cGMPs. • Developed, implemented and maintained QC self-assessment program that resulted in fewer audit observations and raised analyst’s cGMP awareness.• Reviewed and led teams for investigations assuring timely completion, true root cause identification and effective CAPA plans implementations.

Spring House, Pa

Manage a team of 11 analysts overseeing projects and implementing process improvements for efficiencies to support Phase I/II Clinical Manufacturing. Maintain work assignment schedules and review for timely release of raw materials, in-process testing, cleaning verification, and bulk product release in order to ensure uninterrupted clinical trial drug supply. Write, revise, and review SOPs, specification documents, and test methods. Assist with scheduling and review of stability lot testing. Daily troubleshooting to maintain a fully operational laboratory.Selected accomplishments:• Saved $5600 per year by improving efficiencies and reducing redundancies through collaboration with J&J site management and contractors to consolidate lab services.• Improved equipment cleaning as the QC project lead for cleaning validation/verification program compiling and completing the site master plan.• Authored utilities, compressed air and gas trending reports to meet compliance standards and cGMPs.• Reviewed and led teams for investigations assuring timely completion, true root cause identification and effective CAPA plans implementations.

Provide accurate testing, review, training on Detection of Residual Protein Using Fluorescence, Detection of Residual DNA Using Fluorescence, OD280, SDS Page Excel Gel, Nephelometry, Osmolality, Heavy Metals, Nitrates, Chlorine, Conductivity, pH, Color, & Appearance assays in accordance with SOP, Spec-Docs, EP, and USP test methods.Write, revise, and review SOPs, specification documents, and test methods.Assist with IQ and OQs, execute stability testing protocols, perform assay transfer protocols for test scripts, validations, and verifications of assays, computer systems, spreadsheets, and equipment.

Associate Scientist / Pharmaceutical Development Quality Control 2003-2004 Provide accurate testing and review for cGLP and cGMP Phase I, II, and III laboratory testing in accordance with SOP, Spec-Docs, EP, and USP test methods.Successfully transferred the Detection of Residual Protein Using Fluorescence assay and raw material gas testing from Malvern to Spring House.

Facilities start up in the pre-viral direct product capture suites. Quality control start up and then manufacturing support. Utilities sampling and testing, cleaning verification and raw materials testing. Support biochemistry in-process testing and stability testing.

Contributed to establishing high throughput screening organizing 70,000 compounds for general and initial DiscoverWorks Screening. Developed expertise on the TECAN and Sagian liquid handling system. Tested plate replication tracking system for compound data base. Received the President’s award for the Implementation of the High Throughput Screening

Responsible for manufacturing environmental testing products for the detection and measurement of contaminants in soil, water and food.

Bs, Environmental Science

Education record

Education record