GEORGE P HARRIS

646-***-**** acvw81@r.postjobfree.com

PROFILE

Pharmaceutical, Biotech, and Consumer Health manufacturing, production, and packaging background.

Expertise in aseptic processing and cleaning techniques in sterile room environments. Aseptic cleaning and gown certified.

Key skills and knowledge: Continuous Improvement, In Process Checks (IPC), Quality Assurance (QA), Product Verification Inspection (PVI), Workflow Prioritization.

Expert On Job Trainer (EOJT) qualified to conduct Skill Block Checks.

Trained in regulatory safety and compliance: FDA, OSHA, cGMPs, SOPs, PPGs, Safe Start.

Technical skills include: SC Logic Hand Held Scanners, Plateau, Microsoft Office (MS Word, Excel).

Education: Communications Studies – SUNY Bronx Community College, NY PROFESSIONAL EXPERIENCE

Pfizer ( Wyeth, Lederle) Pearl River, NY 2 000 – Jul 2016 Aseptic Vaccine Operator, B iotech/Vaccines Feb 2010 – Jul 2016

● Responsibilities include: operate and monitor production, labeling, packaging, and cartoning equipment used in vial vaccine fill/finish and inspection; maintain logs/batch records. Equipment: Bosch vial washer/depyrogenator, filler, & capper, Eiasi vial inspector, Steris autoclave, chart recorders, flow hoods.

● Work with Media Fill staff to assure product quality.

● Adhere to stringent SOPs: grade classifications of aseptic techniques include A, B, C, D in clean room environment. Gown and Respirator Certification.

● Set up air quality environmental monitoring plates on SAS machines. Take samples from surface plates attached to machinery and personnel to ensure clean room compliance. Trained in environmental monitoring including particle excursion, humidity, temperature, and (DP) differential pressure.

● Transfer production and packaging supplies from holding areas to aseptic production areas.

● Operate Steris autoclave to sterilize filling line components. Perform Leak and Bowie Dick vacuum tests. Core Aseptic Cleaner, Lab Services Apr 2005 – Jan 2010

● Clean and sanitize manufacturing and production facilities in aseptic processing areas (clean rooms). Prepare disinfectants and cleaning solutions using pipettes. Aseptic Cleaning and Gown certified. Packaging Operator, C onsumer Health Feb 2000 – Mar 2005

● Set up, operate, monitor, clean, supply, and load production and packaging equipment including: Resina capper, Lakso cotton & crooked cap detectors, Lepal & Enercon induction sealers, retourqer, Garvey conveyors, Lock metal detectors, NJM labeler, Weldetron wrapper, IWKA, Jones Semi, Jones, Rennington cartoners, validation scales, Omega bundler/heat tunnel, Ackley tablet sorter, Merrill & Lackso tablet fillers, forklift, hand jack, Walker pallet truck, straddle stacker.

● Served as EOJT (Expert on Job Trainer) to train workers and conduct skill block checks.

● Inventory and replenish production, warehousing, and packaging area and lines.

● Inspect products for coding, labeling, tablet count, and quality.

● Assemble fill, pack, seal, and label packages and shipping cartons. Calculate finished units.

● Inspect all outbound materials for proper packaging, labeling, and paperwork.

● Maintained batch records and logs in compliance with SOPs.

● Cleaned and sterilized filling equipment. Performed line clearance.

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