Quality Assurance, Technical Writer, Compliance
Resume:
Joshua E. Straley
**** ***** *** ***** ***** Joy, Pa. 17552 717-***-**** *************@***.***
Summary
Quality Assurance professional with ten years of experience in Quality Assurance and Quality Control in a cGMP manufacturing
environment. Proven abilities in QA/QC compliance, team leadership, technical documentation, communicating to large and
small groups across functional boundaries and process improvement. Possesses strong analytical skills along with problem
solving and investigation skills. Working knowledge of 21 CFR Part 210/211.
Professional Experience
November, 2011 – Present
Glaxo Smith Kline – Marietta, Pa –Pharmaceuticals Manufacturing and Packaging (Contract Position)
Compliance Specialist:
• Writing of SOPs for Warehouse, Master Data and Business Process activities and formatting and review of operational
SOPs.
• Development of training materials for standard operating procedures.
• Author of technical documents to include: CAPAs, Deviations and Change Controls.
• Worked cross functionally to author global change controls, resolve issues in order to progress them to approval.
• Deviation Investigator, responsible for generating deviation trend reports.
• Retention of technical documentation for Warehouse, Master Data and Business Process activities.
August, 2009 – November 2011
Church & Dwight Co., Inc., York, PA – Consumer Products Manufacturing and Packaging (Liquid Laundry Detergent
and Cat Litter)
Quality Technician:
• Analytical and microbiological testing of liquid detergent and cat litter products, inspection and testing of In-Process
materials and product, document management and instrument calibration programs.
• Installation of QC laboratory set-up, equipment, test methods and SOPs for testing of raw materials, intermediate and
final liquid materials and packaged products.
• Writing of SOPs for QA/QC activities and formatting and review of operational SOPs.
• Tracking and reporting of Quality Metrics for Monthly Global Quality Meetings.
• Trending and writing technical summaries of analytical testing data, weight and torque data and component testing data
in support of line performance qualification activities and finished product release.
• Execution of IQ, OQ and PQ protocols for equipment and process implementation at site.
• Execution of environmental monitoring.
July, 2008 to August, 2009
Glaxo Smith Kline – Marietta, Pa –Pharmaceuticals Manufacturing and Packaging (Contract Position)
Technical Writer:
• Writing of SOPs for Packaging and Warehouse Operations and formatting and review of operational SOPs.
• Development of training materials for standard operating procedures.
• Preparation of technical documents to include: CAPAs, GAP Analyses and Change Controls
April, 2005 to July, 2008
D.F. Stauffer Biscuit Co., – York, Pa –Food Manufacturing and Packaging (Cookies and Crackers)
QA/QC Supervisor:
• Developed budget requirements for Quality Assurance activities at plant level.
• Execution of environmental monitoring.
• Collect, prepare and present Quality System metrics in Monthly Management Review Meetings.
• Site representative for QA Operations/QC for external agency inspections including FDA and USDA.
• Drove policies and procedures to ensure timely and appropriate inspection, testing and disposition of Finished Products,
In-process batches, Incoming components including printed materials and raw materials.
• Managed laboratory responsible for in-process and finished product and raw material testing.
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• Ensure that QA inspection staff is properly trained and qualified and development of group goals and assist staff in
implementing goals.
• Auditing of raw material suppliers.
• Execution of internal QA audits.
• Coordination of internal product reviews
• Oversight of Quality Managements Systems to include Hold & Release, HACCP, Document Control, Allergen Control,
Pest Control, Food Safety, GMP and related employee training programs.
• Managed CAPA program and performed investigations in response to non-conforming product including driving
investigations to closure. Follow-up on corrective and preventive actions to assure effectiveness.
August, 2003 to April, 2005
Kegel’s Produce – Lancaster, Pa –Food Manufacturing and Packaging (Fresh-Cut Produce)
QA/QC Supervisor:
• Developed and implemented procedures to ensure timely sampling and testing of finished product.
• Managed laboratory responsible for analytical and microbiological testing of raw materials and finished product.
• Managed policies and
procedures to ensure Food Safety and HACCP prerequisite programs.
• Oversight of GMP,
HACCP and Food Safety related training for all plant employees.
• Compiled incident
investigations and corrective action plans.
• Execution of
environmental monitoring.
• Site representative for QA Operations/QC for external agency inspections including FDA.
May, 2000 to August, 2003
Giant Foods – Lititz, Pa – Retail Department Management (Produce)
Department Manager:
• Supervised a staff of 20 employees
• Conducted monthly inventories and prepared daily orders
• Prepared employee schedules
• Trained new employees
• Ensured GMP and food safety compliance
Certification / Training
AIB Food Safety Course 2005
Computrac Moisture Analyzer Certification 2007
AIB HACCP Certification 2007
Training Skills in the Workplace Penn State Lancaster 2008
ASQ Member 2011
Education
Bachelor of Arts in Telecommunications, Minor in Philosophy May 00
The Pennsylvania State University - University Park, PA 16802
Technical Skills
Word, Excel, PowerPoint, Access, Lotus Notes, AS400/Prism, SAP
Instrumentation
High Performance Liquid Chromatograph, Anton Paar Viscometer, Brookfield Viscometer, Metrohm Autotitrator,
UV Spectrophotometer, Moisture Balance, Rotap
References
Available Upon Request
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