Quality Control A Team

Will Clark

** ********** ***, ******, ** *****

Tel. 201-***-****

Email:*****.******@*****.***

SUMMARY

Over 15 years of GMP experience. Maintained good documentation practice throughout the production process. Great understanding of (cGMP) and FDA regulations. Perform documentation and batch record review.

EDUCATION

H. S. Graduate, Boys & Girls H.S., 1988

PROFESSIONAL EXPERIENCE

Quva Pharma

September 2023- Present

Lead Formulation Engineer

●Managed multi-purpose pharmaceutical development, manufacturing, and packaging campus.

●Specialized in taking both sterile injectable and oral solid drug products from development phase through commercialization.

●Guided and supported a team in production of formulations, ensuring efficient operation and quality control in manufacturing areas of the plant.

●Responsible for coordinating activities like bulk manufacturing, filling, compounding, and sterile filtration of pharmaceutical products, while also adhering to cGMPs and safety regulations.

●Trained and mentored other technicians, as well as performing some manufacturing processing.

IMMUNOMEDICS /GILEAD SCIENCES

February 2021- March 2023

CART T Manufacturing Associate I

●Operated equipment for processing such as cellometer, CliniMACS, Sepax, etc.

●Aseptic Process qualified, cleaned workstations as well as the laboratory to keep the processing area free of contamination.

●GxP compliance skills while filing our MBR’s and logbook management.

●Assisted managers and leads with side project when needed.

●Reviewed logbooks in the laboratory and notify personnel if errors were found.

●Reviewed MBR’s and submitted them to QA batch record review for final review.

●Experienced in System validation of syncade MES within BMS, MBR binding presentation.

●Performed set-up and operation of equipment to support production of lots through cell culture and cryopreservation per standard (SOP’s) in a controlled, CGMP cleanroom environment.

●Managed completion, reviewed and archival of related batch records, and logbooks under GMP guideline.

Sanofi/ Advance Clinical, Ridgefield, NJ

August 2018 – February 2022

Manufacturing Technician Lead 1

●Managed quality control and maintained high level of customer satisfaction.

●Completed preventive maintenance to maintain production and equipment in accordance with safety protocols and company policy.

●Demonstrated excellent mechanical knowledge of machines and tools, including design, use, repair and maintenance.

●Recommended corrective and preventive actions to boost product reliability.

●Drove team performance through effective training, coaching and motivation of line employees.

●Installed and maintained control systems and other technical components to complete equipment installations.

●Reviewed and interpreted schematics, manuals and related documentation to complete mechanical tasks.

●Operated and troubleshot high-speed automated Inspection and Packaging equipment. Typical tasks included loading syringes onto automated inspection equipment, changing label reels, replenishing packaging items (e.g. inserts, labels, cartons, operating syringe)

Assembly machine, thermoformer, cartoner, case palletized, serialization of equipments and wrapping pallets.

●Participate in line changeovers and continuously strive to minimize line downtime. Ensure compliance with cGMPs and SOPs at all times. Perform routine Quality and Safety inspection walk-through of production areas. Perform scheduled cleanings of equipment and packaging rooms.

●Perform routine unit operation tasks for batch record signing. Maintains all associated documentation for operations being performed.

Kari-Out, Totowa, NJ

Lead Compounder/ Shift Supervisor November 2013-March 2018

●Compounding batch pulls for food industry.

●Utilizing GMP protocol to keep batch records accurate.

●Perform CIP on all kettles when changing product, as well as prepare holding tanks for ATP inspection.

●Back flushing all products with accurate lot numbers to maintain SOP logs.

●Keeping material handlers prepared with needed materials to make kits for next batch.

●Heating and cooling batches in preparation for transfer to appropriate holding tanks.

●Train compounders.

ProTech Powders Inc, Fairfield, NJ

February 2010 – November 2013

Lab Technician

●Manage & processed paint batch samples in the qc laboratory.

●Test paint samples to ensure production standard/quality for client’s order.

●Inform batch maker to proceed with current batch or direct them to redo the batch if not up to standards.

●Coordinate with line operators to match color standard with the appropriate pantone color against client’s color request.

●Blend formulations for soft gel production.

Tris Pharma, Monmouth Junction, NJ (Acquisition)

September 2008 – February 2010

Chemical Operator

●Operated Three-Dimensional HMI Manufacturing Equipment. Dispensed, weighed and compounded products while maintaining product logbook.

●Operated packaging equipment (tablet filler, thermo former labeler, case packager, etc.

●Performed quality attribute inspections and in-processing testing, seal integrity, leak test, and appearance.

●Verified corrections of product and components.

●Received drug substances, raw materials and blend dry powder formulations.

●Operated, assembled, and cleaned mixing equipment, transferred formulations from one type of container to another, conditioned experiments, and worked with analytical support.

●Supported formulation development activities across departments.

●Read and evaluated safety data sheets.

●Blend uniformity analysis of powders.

●Worked with analytical group to ensure the formulations were tested and interpreted data.

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