JoAnna Havis
Colbert,WA
Summary
Forward-thinking validation expert with more than 13 years of experience in sterile manufacturing operations including process design and qualification. Experience includes, Steam Sterilization, Cleaning and Process Validations and Environmental Monitoring. Known for great time management, effective multitasking and detail-oriented planning.
Overview
13
13
years of professional experience
Work History
Manufacturing Science and Technology-Supervisor
Jubilant HollisterStier
07.2018 - Current
- Author Protocols and Acceptance Reports for Process Performance Qualifications including cleaning, steam sterilization and manufacturing process performance qualifications.
- Perform investigations for process and material deviations, driving to root cause and assist in implementation of CAPAs designed to empower flawless execution.
- Ensure all applicable U.S. European regulatory requirements are being met within MS&T owned procedures and practices.
- Contributed to completion of risk assessments and gap assessments for continued process improvement.
- Maintain material specifications and work closely with material vendors to ensure compliance with relevant regulatory requirements.
Environmental Monitoring Supervisor
Jubilant HollisterStier
06.2015 - 07.2018
- Developed and maintained Environmental Monitoring Program
- Review and approval of all Environmental Monitoring SOPs to ensure compliance with regulatory documents.
- Implementation of FacilityPro and MODA Monitoring System.
- Implemented standardized training program for laboratory procedures.
Quality Assurance Associate
Jubilant HollisterStier
12.2014 - 06.2015
- Complete daily audits and provided QA oversight of all manufacturing areas
- Provide input and assistance in investigation review including root cause analysis
- Collaborate in review and revision of Standard Operating Procedures.
Database and Investigation Technician
Jubilant HollisterStier
01.2014 - 12.2014
- Review and Record Environmental Monitoring Data
- Issuance and completion of Alerts/Actions/Incidents pertaining to EM data excursions
- Assist with investigations related to EM Data and provide trend analysis
EM Technician
Jubilant HollisterStier
09.2010 - 01.2014
- Perform monitoring of classified areas and collect utility and product samples
- Review and verification of controlled documents
Education
Bachelors of Science - Chemistry/Biochemistry
Eastern Washington University
Cheney, WA2009
Skills
- Proven leadership skills
- Experience in qualification and validation of processes and equipment
- Thorough knowledge of Environmental Monitoring requirements and technologies
- Experienced technical writer
- Familiar with industry software applications including MODA, SAP, Trackwise, BMRAM and MasterControl Documentation systems
- Familiar with Minitab and JMP statistical software
- Knowledge Of Quality Systems
Timeline
Manufacturing Science and Technology-Supervisor
Jubilant HollisterStier
07.2018 - Current
Environmental Monitoring Supervisor
Jubilant HollisterStier
06.2015 - 07.2018
Quality Assurance Associate
Jubilant HollisterStier
12.2014 - 06.2015
Database and Investigation Technician
Jubilant HollisterStier
01.2014 - 12.2014
EM Technician
Jubilant HollisterStier
09.2010 - 01.2014
Bachelors of Science - Chemistry/Biochemistry
Eastern Washington University
Similar Profiles
MITCHELL LUKESMITCHELL LUKES
Process Technician IV at Jubilant HollisterStierProcess Technician IV at Jubilant HollisterStier
Megan FindleyMegan Findley
Pharmaceutical Manufacturing Technician at Jubilant HollisterStierPharmaceutical Manufacturing Technician at Jubilant HollisterStier
Elizabeth MontgomeryElizabeth Montgomery
Environmental Monitoring Associate at Jubilant HollisterStierEnvironmental Monitoring Associate at Jubilant HollisterStier