Sr. Quality Assurance Resume
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Resume:
Professional Profile
Joe Helmstetler has nearly years of professional experience in compliance and quality assurance (QA) working in a regulated manufacturing environment (pharmaceutical). He has extensive experience in conducting investigations of deviations occurring during any part of the production process, audit findings, and complaints.
He has acted as Lead Document Controller performing tasks such as review & approval of issued Batch Production Records (BPR), incidents affecting BPR documentation in all areas during each the manufacturing process, Out of Specification (OOS) and Out of Trend (OOT) analytical events, packaging issues, incoming complaints, etc. He performed batch review and disposition.
As a Quality Assurance Representative, Joe served as de-facto supervisor to operations personnel in the absence of their direct supervisor. These responsibilities included responding to employee questions and concerns. Making decisions related to production and packaging. He has also trained employees on current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Standard Operating Procedures (SOP)s, aseptic practices, and provided coaching as necessary.
Joe served as a Subject Matter Expert (SME) in Root Cause Analysis (RCA) and performed RCA in response to deviations, audit findings, customer complaints, etc. Once RCA was completed Joe developed Corrective and Preventative Actions (CAPA), and conducted follow-up Effectiveness Checks to ensure CAPAs were working as intended.
He has conducted dozens of Gap-Analysis tasks and developed Action Plans in order to ensure compliance with internal & corporate global SOPs, GMPs, and requirements as laid out by domestic (FDA, DEA) and foreign regulatory bodies.
He has experience pertaining to validation of equipment, methods, and procedures.
He has experience working with various software such as Sparta Systems Trackwise quality management system &#;QMS&#;, DMI Regulus/Compliance Suite for document control, and Microsoft Office Suite including building databases using Microsoft Access and analysing data in Microsoft Excel, and acted in an information technology (IT) capacity performing both user and network support.
Systems Expertise & Special Skills
- Quality Management Systems
- Production Systems
- Laboratory Controls Systems
- Materials Handling Systems
- Packaging and Labeling System
- Document Control Systems
- Change Control Systems
- Investigations – Deviation, OOS, OOT, Complaints, Audit Findings
- Continuous Improvement
- Gap-Analysis & Remediation
- Corrective & Preventative Actions (CAPA)
- Effectiveness Evaluations
- Batch Release / Disposition
- Total Quality Management (TQM)
- Auditing – Self, External, Internal, Cross Functional, Supplier
- Root Cause Analysis (RCA) SME
- Trackwise Instructor
- Technical Writing
Joe Helmstetler
Quality Assurance Specialist
Professional Experience
- Consultant
- 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
- Lead Investigator / Root Cause Investigation & Analysis Engineer
- Conduct approximately % of Deviation and out of specification (OOS) laboratory result investigations in order to determine impact to product safety, identity, purity, and quality (SISPQ).
- Conduct approximately % of Complaint Investigations
- 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 transition from paper based system for deviations, RCAs, CAPAs, etc. to corporate system – Sparta Systems Trackwise.
- Regulus – Lead 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 shipping. After determination of whether criteria for release are met, determine batch disposition for % of batch production records (BPR).
- Trainer
- Trackwise – Sole on-site trainer for the technological & methodological use of Trackwise
- SOPs – Instruct personnel on new and existing standard operating procedures SOP. Train supervisors on the writing of SOPs in the proper style.
- 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.
- Lead Document Controller
- 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 subject matter expert (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 records (DMF).
Joe Helmstetler
Quality Assurance Specialist
- 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
Certifications
- Comptia A+
Professional Associations
- Pharmaceutical Technical Exchange Association (PTEA)
EDUCATION
- S. Psychology, Kansas State University of Kansas
Employment Experience[] See Footnote
HOW Enterprises LLC
Quality Consultant / Sept. – Present
Elanco Animal Health
QA Representative / December – September
Elanco – Ivy Animal Health
QA Associate, Manufacturing / January – December
Ivy Animal Health
QA Lead Document Controller / September *- January
[]- Employed at Ivy Animal Health through staffing agency ProStaff. ** Hired in September as Ivy Animal Health employee. ** In Elanco, Eli Lilly & Co.’s Animal Health Division, acquired Ivy Animal Health **- Ivy Animal Health was held as a wholly owned subsidiary of Lilly/Elanco **-Present Ivy Animal Health changed into, by name and administratively, an official Elanco site: Elanco Kansas City
