Quality Insurance Specialist Resume
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Resume:
Professional Profile
Joe Helmstetler has nearly years of professional experience in compliance and quality assurance working in a regulated manufacturing environment (pharmaceutical). As a Lead Investigator he performed investigations into + deviations per year, audit findings, performed dozens of gap analysis. He acted as a Subject Matter Expert (SME) in root cause analysis (RCA), and devised corrective & preventative (CAPA) actions for any investigative findings. His investigative experience extended to any other anomalies occurring during the production process including out of specification (OOS) analytical findings, as well as any out of trend (OOT) results. He has conducted dozens of gap-analysis tasks in order to ensure full compliance. All of these tasks required extensive technical writing experience.
He has experience pertaining to validation & qualification of equipment prior to process validation. He has experience working with various software such as Sparta Systems Trackwise quality management system &#;QMS&#;, DMI Regulus/Compliance Suite for document control both of which he was involved in rolling out to the entire site. He has experience with other software including McLaren EDMS for technical drawings. His experience with Microsoft Office Suite extends beyond common use of Excel, Power Point, etc. but also included building SAP style databases using Microsoft Access. He also has experience in an information technology (IT) capacity performing both user and network support.
System Expertise – Quality
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· Deviation, OOS, OOT Investigation · Continuous Improvement · CAPA · Effectiveness Evaluation · Document Control · Manufacturing Resource Planning (MRP) · Batch Release/Disposition · Trackwise QMS by Sparta Systems
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· Label Control · RCA · Change Control · Total Quality Management · Gap Analysis · Auditing Internal, Cross Functional, Supplier · Quality Audits · Regulus DMS by DMI International
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Professional Experience
HOW Enterprises LLC
Quality Consultant Sept. – Present
- Determine Critical Control Points
- Develop Hazard Analysis Critical Control Point (HACCP) implementation
- Devise and write Standard Operating Procedures
- Implement systems for the investigation of deviations from procedure/policy
- Establish Corrective and Preventative Action system
- Create system to monitor effectiveness of CAPAs
Eli Lilly Elanco
QA Representative Manufacturing, Jan. – Sept.
Lead Investigator / Root Cause Investigation & Analysis Engineer
- Conduct Deviation and out of specification (OOS) laboratory result investigations in order to determine impact to product safety, identity, strength, purity, and quality (SISPQ).
- Conduct root cause analysis (RCA) in order to determine the failure mode relating to deviations, audit observations, and complaints.
- Devise corrective and preventative actions (CAPA) based on the results of the root cause investigation and analysis (RCI/RCA), and perform Effectiveness Evaluations of CAPAs.
Project Leader
- Trackwise – Lead roll out of Trackwise to the Overland Park, KS site, and lead the transition from paper based system for deviations, RCIs, CAPAs, etc. to Sparta Systems Trackwise.
- Regulus – Lead the roll out of Regulus to the Overland Park, KS site as well as the transition from paper based system of document control to corporate system.
Batch Releaser
- Complete manufacturing batch record review to ensure current Good Manufacturing Practices (cGMP) were followed during all phases of production including manufacturing, laboratory/analytical, packaging, and labeling. After determination of whether criteria for release are met, determine batch disposition.
Trainer
- Trackwise – Sole on-site trainer for the technological & methodological use of Trackwise
- SOPs – Instruct personnel on new and existing standard operating procedures SOP.
- Documentation – Instruct personnel on Good Documentation Practices (GDP).
- cGMP – Assist in instructing personnel in cGMP and Lilly Global Standards.
- Audits – Instruct personnel in procedures for conducting internal and cross functional audits of manufacturing process.
- Investigations – Taught prospective investigators methods used during, deviation, RCA/RCI, and OOS, and OOT investigations.
- Software – Instructed users in the operation of corporate systems and Microsoft applications as needed.
Lead Auditor
- Act as Lead Auditor using GMP, ICH, and ISO guidelines to ensure compliance with regulations and adherence to GxPs and local SOPs during QA self-inspections, facility/operations during cross functional audits, as well as supplier audits.
Ivy Animal Health
Lead Document Controller & QA Associate -
- Perform Document Control duties including development of good documentation practices systems, document review, document approval, document routing
- Write standard operating procedures (SOP), and ensure good documentation practices are followed.
- Act as a SME in document approval and routing as well as the generation of batch records in Regulus. Assist in the generation of Annual Product Reviews (APR) and Drug Master File &#;DMF&#; records.
Technology Support Specialist
- Troubleshoot networking issues with the IT team located in Georgia.
- Review & approve Computer Systems Validation (CSV) documents.
- Performed in a Computer Systems Quality Assurance (CSQA) capacity.
- Handle all end user desktop/laptop trouble ticket requests for ~ employees at the Overland Park, KS location.
- Build and maintain databases for SOPs, tracking training, batch record data, purchase orders, packing slip/order entry – use of some of these databases ended in after ~ years of performance.
- Assist the global transition team in taking inventory of all computer systems in use at the site, describe application functionality, purpose and frequency of use, compiled number of system users, user level, etc.
- Aid in installation of and training on new systems.
- Act as site liaison throughout the transition period and through post-transition issues.
TRAINING
- Technical Writing
- Investigations
- Root Cause Analysis
- Trackwise Instructor
- CAPA
- Trackwise
CERTIFICATIONS
- Comptia A+
- Eli Lilly & Co Trackwise Champion
PROFESSIONAL ASSOCIATIONS
- Pharmaceutical Technical Exchange Association (PTEA)
EDUCATION
- S. Psychology, Kansas State University
