Senior Quality Control Chemist
Resume:
Haltom City, TX *****
**************@*****.***
Experience:
February 2017 – Present Smith & Nephew, Inc. Fort Worth, TX
Senior Quality Control Chemist, previously Quality Control Chemist
Hired initially as QC Chemist for technology transfer of entire pharmaceutical manufacturing process from third party contract manufacturer to in-house facility
Highly involved in instrument selection and qualification to bring chemistry lab online
Responsible for transferring 18 analytical methods and all necessary components including protocol and report writing, method, procedure, and form creation, and validation testing
Promoted to Senior Chemist after 2 years and became the lead in the chemistry lab for other analysts
One of 2 analysts embedded at contract manufacturer for 2 months to become qualified on all methods and lead transfer of testing methods in-house for intermediate drug substance, API, and finished product stages
Supported regulatory filing with validation reports and most responsible person responding to FDA post-inspection questions
Presented and defended all method validations to FDA Investigator during Pre-Approval Inspection
Introduced 5S and Lean process improvement initiatives in the lab to streamline workflow in a limited space while ensuring adequate resources for individual projects
Tapped to lead team and perform spreadsheet validation with no on-site expertise readily available
In charge of instrument maintenance management with manufacturers for multiple highly technical analytical instruments
Lead investigator for lab non-conformances and integral member of CAPA and Change Control processes
Led manufacturing support testing as in-house manufacturing process performance qualification began
Primary reviewer of assays performed by other analysts
Led qualified training program for analysts
Responsible for standard and reagent qualification program to ensure preparation and qualification of items in-house and no longer rely on the third party manufacturer
Schedule and perform routine testing and responsible for continuous inventory control
Responsible for document maintenance of dozens of SOPs, SMAs, and Forms
Testing to support production process improvements
Coordinate with the stability team to test manufactured lots
October 2015 – February 2017 American Pharmaceuticals and Cosmetics Fort Worth, TX
Analytical Chemist
Extensive use of HPLC instruments for assay quantification, derivatization of certain chemicals and antibiotics, and degradant quantification and identification
Control the stability program of 4 separate stability conditions and the library of retention samples of all batches
Validation, verification, and qualification work as needed around the lab for instruments or assay procedures
Identification of materials by UV-Vis Spectrophotometry and FTIR Spectroscopy
April 2012 – Sept 2015 American Fruit Processors Pacoima, CA
Quality Control Chemist
Sampled and tested all incoming Raw Materials to ensure compliance before they were used and compiled Critical Control Point documents, Certificates of Analysis, and Safety Data Sheets
Adjusted in-process batches using a Quality Systems regulation scheme based on titration and measured sugar level
Inspected entire plant monthly for physical inconsistencies and assurance of Good Manufacturing Practices and reported findings to pertinent departments for remediation of various issues
Continually followed HACCP and cGMP rules and regulations by abiding by our Safe Quality Foods (SQF) plan as well as changing local, regional, national, and international policies
Education:
Bachelor of Science, Biology May, 2010 San Diego State University San Diego, CA
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