SUMMARY

• Use micrometers, Vernier calipers, tensile strength equipment and micro - vue readers to verify specifications of custom extrusions for medical device use.
• Calculate AQL for the start of a new run. Adjust AQL as needed during the run.
• Document all results in the company’s computer data system.
• Alert machine operators of all NCM’s and report them to the supervisor.
• Participate in CAPAs as needed.

PROFESSIONAL EXPERIENCE

Confidential

Rebin Associate

Responsibilities:

• Sorted items for the packaging department.

Confidential

Quality Assurance Scientist

Responsibilities:

• Checked AQL report for accuracy and adjusted the AQL as needed during runs.
• Verified cleaning log books prior to start up.
• Responsible for verifying all components that production logged into the batch record prior to start up.
• Performed hourly checks, inspections, and counts using vacuum leak tester, torque tester and micrometers as needed.
• Recorded daily challenges with the mechanic.
• Pulled FSC and customer samples as established in the batch record. Recorded in- house retains before storage.
• Verified all pallet counts before released to the material handler.
• Verified all waste logs and reconciliation.

Confidential

IC/QA

Responsibilities:

• Responsible for inventory control and quality assurance using a handheld RF scanner.
• Offered the position as a coach for the upcoming “height pick” season.

Confidential

Quality Assurance Scientist

Responsibilities:

• Responsible for hourly checks to monitor temperature, laser coding, pH, conductivity, cap torque, packaging, pouch weights and verify employee’s paperwork.
• Tested and released the product and raw ingredients using Brix, pH, viscosity and total solids.
• Performed stability checks on five day incubation products and one year shelf life products.
• Scaled down studies to determine the amount of acidification for batches.
• Tested and released batches for production.
• Took pictures of products that had to be quarantined for reconciliation.
• Monitor temporary employees to insure GMP regulations were being followed.
• Document all data according to GMP standards and record in Excel.
• Allergen tested for dairy, gluten and coconut.
• ATP swab to verify the CIP process.
• Participated in CAPA investigations.
• HACCP and SQF trained.

Confidential

Quality Technician I

Responsibilities:

• Audited all phases of pet food quality including flow rate for pasteurization, sensory exams and ingredients used.
• Checked all workers every two hours to insure the accuracy of their documentation.
• Released raw and frozen material after verifying the specifications.
• Released dry material after verifying correct usage and specifications.
• Released final products and when necessary held products.
• Verified and monitored fat and moisture of products in progress and final products.
• Determined X and R bar factors.
• Verified can cutting results.
• Checked laser jet printers for accuracy.
• Performed day old and two week old product checks for consistency and vacuum.
• Attended all safety and Dupont Stop programs.
• Investigated can damage (droops, vees and wooling)
• Recorded and released results in SAP system.
• HACCP trained.

Confidential

Quality Assurance Scientist

Responsibilities:

• Responsible for analytical testing of beer, cider and tea at various stages to insure that specifications were met.
• Determined the results using gas chromatography, spectrophotometry, DMA alcolizer, titrations, bitter unit assay, pH, conductivity, haze potential, diatomaceous earth filtration and SO2 analysis for the cider.
• Recorded results using the LIMS system and released final batches.

Confidential

Associate Scientist I, Purification Development

Responsibilities:

• Responsible for purification of monoclonal antibodies using various chromatographic techniques such as affinity, ion exchange, HIC, etc., as well as membrane technology techniques and TFF for optimization of process time and cost efficiency.
• Lead scientist responsible for conducting Phase I / II /III Viral Clearance studies including generation of Viral Validation Reports.
• Performed stability testing on product through all phases of the purification process and documented the results in lab book, technology transfer and/or stability reports.
• Recorded all process steps and final results in technology transfer reports for production supervisors to generate batch records for upscale runs.
• Contributed in all phases of process characterization study; ranging from running chromatography (using GE AKTA Explorer with Unicorn software) to sample analysis using various analytical techniques including: HPLC (using Waters HPLC with Millennium/Empower software), OD280, ELISA, qPCR (using ABI Prism 7000), and SDS-PAGE with Coomassie or silver stain.
• Assisted in Toxicology purification, aseptic filling and labeling. cGMP trained professional capable of carrying out and documenting manufacturing tasks including column packing, chromatography and tangential flow filtration for primary recovery, in-process buffer exchange and final product formulations.
• Performed virus removal filtration using Viresolve and/or Planova filters including membrane integrity testing.
• Responsible for the review of cGMP batch records as well as recording manufacturing tasks in compliance with company guidelines.
• Participated in CAPA investigations.
• Assisted in buffer preparation and other miscellaneous tasks needed to ensure the timely completion of product purification.
• Trained in Hazmat and -80° shipping (using specialized thermometers to insure the product remained at the recommended temperature) by way of UPS and FedEx.