Product Development Quality System
Resume:
Laura R. Borja
West Jordan, UT 84084
Cell 385-***-****
Email: **************@*****.***
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Education AA Degree July 1996 – Dec. 1998 Taft Community College Taft, CA Experience
QUALITY SYSTEM SPECIALIST III April 2019 - Present Wasatch Product Development Draper, UT
• Conduct Audits on internal Batch records.
• Review records and documents, for completeness and compliance with QSR
• Generate standard operating procedures to define and improve quality system functions.
• Support the electronic documentation process as needed.
• Lead and participate in interdepartmental initiatives for continuous improvement.
• Provide companywide training on general quality principles and specific procedural requirements.
• Facilitate process improvement within other departments, through the use of training, coaching, and team participation.
• Support the corrective action program, with hands on ownership for investigation and resolution of issues.
• Conduct investigations and resolve product and process problems related to quality issues.
• Maintain the master stability file.
• Pull stability testing when is needed.
• Create stability reports and create validation reports.
• Participate in the internal auditor program.
• Maintain computerized quality databases.
• Perform other duties as assigned or needed.
• Understand and adhere to GMP policies and procedures. DOCUMENT CONTROL SUPERVISOR June 2014 - April 2019 Wasatch Product Development Draper, UT
• Conduct Audits on internal Batch records.
• Review records and documents, for completeness and compliance with QSR
• Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components, and instrumentation-related products.
• Generate standard operating procedures to define and improve quality system functions.
• Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
• Support the electronic documentation process as needed.
• Lead and participate in interdepartmental initiatives for continuous improvement.
• Provide companywide training on general quality principles and specific procedural requirements.
• Facilitate process improvement within other departments, through the use of training, coaching, and team participation.
• Support the corrective action program, with hands on ownership for investigation and resolution of issues.
• Participate in the internal auditor program.
• Follow safety procedures.
• Oversee environmental monitoring tasks.
• Retention Program.
• Assist with training of Inspectors.
• Provide Regulatory documentation to Foreign Subsidiaries.
• Release of stock items physically and in company ERP database.
• Assign daily responsibilities to Inspectors.
• Assist with track employee attendance and productivity.
• Monitor productivity to ensure adequate training.
• Maintain computerized quality databases.
• Perform other duties as assigned or needed.
Laura R. Borja
6921 S Jordan Village Rd
West Jordan, UT 84084
Cell 385-***-****
Email: **************@*****.***
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• Understand and adhere to GMP policies and procedures. DOCUMENT CONTROL SPECIALIST III Oct. 2008 – May 2014 Wasatch Product Development Draper, UT
• Conduct Audits on internal Batch records.
• Create Certificate of analysis for manufactured lots
• Prepare samples for Third party testing.
• Scanning and electronically filing documents
• Sending reports to customers
• Monitor manufacturing and environmental processes to ensure manufactured products meet necessary quality standards.
• Maintain the company’s quality assurance system to ensure manufactured products meet necessary quality standards.
• Investigate and review quality processes to ensure compliance with Good Manufacturing Practice and quality system requirements.
• Conduct audits of internal quality systems to ensure compliance with company standards.
• Conduct investigations and resolve product and process problems related to quality issues.
• Maintain company quality assurance archives.
• Maintain computerized quality databases.
• Perform other duties as assigned or needed.
• Understand and adhere to GMP policies and procedures. QUALITY CONTROL INSPECTOR III Oct. 2008 - May 2014 Wasatch Product Development Draper, UT
• Conduct quality control tasks including inspecting and sampling raw materials, finished products, general merchandise, components, and using a Near Infrared Spectrophotometer.
• Creating quality control documentation including inspection worksheets, Certificates of Analysis, Certificates of Compliance, reports, and Batch Production Records.
• Oversee the cleaning and maintenance of inspection equipment and suites.
• Monitor and inspect manufacturing and warehouse functions for cGMP compliance.
• Monitor vendor performance and history.
• Assist with internal quality audits.
• Assist with operational and quality deviations.
• Follow safety procedures.
• Oversee environmental monitoring tasks.
• Assist with training of Inspectors.
• Process development and implementation of new procedures.
• Prepare and review component specifications for general merchandise.
• Assist with employee interviews and annual reviews.
• Expedite items with coordination between inspectors, Quality Control lab, and all other departments.
• Assist QC Supervisor with Part number requests and Process Management implementation.
• Order supplies for QC Department.
• Perform other duties as assigned or needed.
• Understand and adhere to GMP policies and procedures. Skills MS Office, Outlook, Excel, Word, Internet, 10 key, Bilingual (Spanish), Word Processing, Printer, Copy Machine, Fax, Computer, Matrix-F Near Infrared Spectrometer, Microbiological Air Sampler MAS-100, Airborne Particle Counter APC-1000, Standard Caliper, Excel, Scanner, Encoding Machine, Close attention to detail.
Laura R. Borja
6921 S Jordan Village Rd
West Jordan, UT 84084
Cell 385-***-****
Email: **************@*****.***
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Interests Sports, Music, Swimming, Learning new things, Cooking, Volunteering, Hiking, and a good challenge.
References
• Laura Heraldez 661-***-****
• Manila Pech 801-***-****
• Alejandra Jimenez 801-***-****
Contact this candidate