Joe Helmstetler

Quality Assurance Specialist

*** * *******

Gardner, KS 66030

913-***-****

acwgf7@r.postjobfree.com

Professional Profile

Joe Helmstetler has nearly 15 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 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

Information Technology Systems

Packaging and Labeling Systems

Document Control Systems

Change Control Systems

Investigations – Deviation, OOS, OOT,

Complaints, Audit Findings

Gap-Analysis & Remediation

Corrective & Preventative Actions (CAPA)

Effectiveness Evaluations

Desktop/Laptop//Network Support

Total Quality Management (TQM)

Auditing – Self, External, Internal, Cross Functional, Supplier

Root Cause Analysis (RCA) SME

Trackwise Instructor

Technical Writing

Professional Experience

Technology Support Specialist

oTroubleshoot networking issues with the IT team located in Georgia.

oReview & approve Computer Systems Validation (CSV) documents.

oPerformed in a Computer Systems Quality Assurance (CSQA) capacity.

oHandle all end user desktop/laptop trouble ticket requests for ~60 employees at the Overland Park, KS location.

oBuild and maintain databases for SOPs, tracking training, batch record data, purchase orders, packing slip/order entry – use of some of these databases ended in 2011 after ~10 years of performance.

oAssist 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.

oAid in installation of and training on new systems.

oAct as site liaison throughout the transition period and through post-transition issues.

Project Leader

oTrackwise – Lead transition from paper based system for deviations, RCAs, CAPAs, etc. to corporate system – Sparta Systems Trackwise.

oRegulus – Lead transition from paper based system of document control to corporate system.

Trainer

oTrackwise – Sole on-site trainer for the technological & methodological use of Trackwise

oSOPs – Instruct personnel on new and existing standard operating procedures SOP. Train supervisors on the writing of SOPs in the proper style.

oDocumentation – Instruct personnel on Good Documentation Practices (GDP).

ocGMP – Assist in instructing personnel in cGMP and Lilly Global Standards.

oAudits – Instruct personnel in procedures for conducting internal and cross functional audits of manufacturing process.

oInvestigations – Taught prospective investigators methods used during, deviation, RCA/RCI, and OOS, and OOT investigations.

oSoftware – Instructed users in the operation of corporate systems and Microsoft applications as needed.

Lead Investigator / Root Cause Investigation & Analysis Engineer

oConduct approximately 40% of Deviation and out of specification (OOS) laboratory result investigations in order to determine impact to product safety, identity, purity, and quality (SISPQ).

oConduct approximately 90% of Complaint Investigations

oConduct root cause analysis (RCA) in order to determine the failure mode relating to deviations, audit observations, and complaints.

oDevise corrective and preventative actions (CAPA) based on the results of the root cause investigation and analysis (RCI/RCA), and perform Effectiveness Evaluations of CAPAs.

Technical Writer / Investigator

oThe Production Technical Writer is responsible for creating SOPs, batch records, writing deviations/Investigations and completing CAPA.

oTrack and trend miscellaneous cGMP Data for Production

oPrepare and review written procedures and documentation, including SOPs, Master Batch Records, Specifications, and other related documents

oFollow requirements of batch records, SOPs, test methods, validation protocols, validation reports, calibration, and change control records to administer quality and compliance into processes

oPerform other duties as assigned

oWrite Standard Operating Procedures (SOPs) for various departments

oWrite Batch Records for new products

oInvestigate Deviations

oPerform Root Cause Analysis (RCA)

oEstablish Corrective and Preventative Actions (CAPA)

oWrite Deviation reports containing RCA and CAPAs for Deviations

Consultant

oDetermine Critical Control Points

oDevelop Hazard Analysis Critical Control Point (HACCP) implementation

oDevise and write Standard Operating Procedures

oImplement systems for the investigation of deviations from procedure/policy

oEstablish Corrective and Preventative Action system

oCreate system to monitor effectiveness of CAPAs

Batch Releaser

oComplete 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 100% of batch production records (BPR).

Lead Auditor

oAct 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

oPerform Document Control duties including development of good documentation practices systems, document review, document approval, document routing

oWrite standard operating procedures (SOP), and ensure good documentation practices are followed.

oAct 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).

Training

End User Desktop Support

Networking Support

Technical Writing

Investigations

Root Cause Analysis

Trackwise Instructor

CAPA

Certifications

Comptia A+

Professional Associations

Pharmaceutical Technical Exchange Association (PTEA)

EDUCATION

B.S. Psychology, Kansas State University of Kansas

Employment Experience

Aerotek

Nostrum Laboratories

Technical Writer - Investigator / July 2016 - Present

HOW Enterprises LLC

Quality Consultant / Sept. 2015 – Present

Elanco Animal Health[1] See Footnote

QA Representative / September 2002 – September 2015

oElanco – Ivy Animal Health

QA Associate, Manufacturing / January 2007 – December 2010

oIvy Animal Health

QA Lead Document Controller / September 2002 - January 2007

1 Elanco Kansas City acquired Ivy Animal Health which remained a subsidiary until eventually transformed into an Elanco site

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