Quality Systems Associate of ISO 9001:2015 and ISO 17025:2017 manufacturer of Particle counters and environmental monitoring systems.In charge of calibration, documentation, shipping, and distribution of over 1000 pieces of domestic and international pieces of equipment used in the manufacture and service of products.Third party trained on performing Internal Auditing and Lead Auditor duties.Perform internal audit duties twice per year, and lead auditor duties on a rotating basis.Review, update, and release quality categorized related documentation for use in the facility.Respond to outside customer surveys for both electronic and life science industries.Create, administrate, and approve CAPAs and Temporary Deviations.Administer monthly Key Performance Indicators in accordance with ISO 9001:2015.Cohost both third party assessors and customer audits.

Contributed Quality control information, data, and specifications for individual products for Annual Product Review Report.Responsible for creation, modification, and inactivation of user accounts on non HPLC GMP equipment.Wrote and executed laboratory instrument protocols.Transferred to Corden Pharma when Hospira was acquired by Corden Pharma. Resumed duties described in Corden Pharma employment section

Duties include validation of outside client methods for a variety of products. This may include but not limited to purchasing materials (HPLC and GC columns), execution of initial methods, providing feedback on limitations while also providing suggestions on improving performance. Responsibilities may also include co-validation of a analytical method with client analysts, as well as running the method prior to transfer to quality control.

• New group as of January 1, 2014 helped to define duties and transition system responsibilities from laboratory personnel. Originally ten system owners of equipment was streamlined to two.• System Ownership of over 100 laboratory instruments including HPLC’s, UPLC’s, Mass Specs, Centrifuges, CE’s, UV Vis, Biophysical equipment and pipettes for scientists in five different research groups. • Duties included contacting, coordinating, and scheduling field engineers to perform instrument preventative maintenance and repairs, while limiting the impact on the scientists within the lab. • Responsible for instrument paperwork, including preventative maintenance, new instrument information, out of tolerance evaluations for audit purposes. Also maintaining instrument information in databases, electronic logbooks, and inventory spreadsheets.• Able to research, order, and acquire hard to find chemicals, materials, and equipment.• Reviewed annual vendor contracts for accurate instrument information also implemented a 90-day pre-approval of contracts to prevent delays in service.• Became group’s SME on Maximo database.• Obtained quotes from outside vendors to have instruments moved to other Amgen sites.• Became a leader on obtaining information and solving problems related to contact information regarding scientists, field service engineers, or contract information.

• Studied both Native and Denatured thiol groups in several large molecules via Ellman’s assay. Testing involved both established methodology, and time study experiments.• Evaluated a large molecule method via reverse phase HPLC for durability and reproducibility, as well as gave recommendations for improvement.• Prep mobile phases for other scientists, to expedite testing.• Logged in new chemicals and disposed of expired ones, physically and within chemical database.• Performed size exclusion chromatography on a wide array of manufacturer HPLC columns for a sister site. The result was a column easier to obtain, better chromatography, and more cost effective.• Improved operational efficiency by developing a system to prevent loss of preventative maintenance paperwork, and created a spreadsheet to track and replace individual pipettes when sent out for preventative maintenance.• Collected, prepped, disinfected, and submitted pipettes for scheduled preventative maintenance (Role was expanded when transferred to central services).

A variety of physical and chemical testing API raw materials and excipients for various pharmaceutical needsTesting on finish product samples used for release and stability information.On safety committee which had a span of over 2 years without an OSHA recordable incident, contributed the annual revision of the laboratory Chemical Hygiene PlanA control substance keyholder responsible for distributing samples for testing also was heavily involved in the yearly reconciliation of all controlled product samples.Contributed to the revision and streamlining of SOP’s to be more user friendly while maintaining GMP compliance.Gave recommendations on possible OOS assignable causesHelped design and execute special testing protocols to evaluate possible manufacturing issues or vendor supply issues.Involved in the evaluation of methods which were going from development to quality control for clarity, reproducibility, inconsistencies, material availability, and safety.