Robert C. Ellis
Summary
Quality Management professional with successful career delivering efficiency and standardization, and maintaining all cGMP, ISO, and QS 9000 and Six Sigma Quality Systems. Drives smooth operation of production and manufacturing lines, coordinate efforts of employees and facilitate communication between management and production departments. Apply creativity in improving manufacturing process to achieve higher productivity and quality of finished goods. Experience in reviewing and interpreting regulatory and programmatic guidance, implementation of corporate compliance, risk management and corrective action programs.
Overview
32
32
years of professional experience
Work History
Produce Associate 1
Sam’s Club
08.2023 - Current
- Company Overview: A division of Walmart Inc., we are the membership warehouse club solution for everyday living
- Worked with the produce team to insure that daily incoming product was verified against the manifest and stock was appropriately rotated
- Routinely quality checked produce department to ensure all product were fresh, in date and meeting member and company expectations
- Greeted members with a smile and answering any questions the member may have
- Maintained a clean department to ensure the highest quality product in the highest quality environment
- Worked with teammates from other shifts to ensure good communication in order to exceed member and company expectations
- Stocked fruits and vegetables and removed old or poor quality products.
- Maintained high standards of cleanliness throughout the produce department, adhering to all health code regulations for food handling.
- Assisted with weekly inventory counts.
Quality Assurance Manager
BioLab Sciences
10.2022 - 12.2022
- Company Overview: BioLab Sciences is a regenerative medicine company focused on creating new ways to regenerate the body for optimal performance
- Managed and provided oversight of the quality system and483/warning letter corrective actions outlined by the company response
- Performed internal audits to identify further gaps in compliance with FDA regulations Parts1271,210/211 and600
- Helped close open investigations
- Performed internal audits of the environmental monitoring program and cleanroom cleaning process
- Mentored QA staff on cGMP and cGTP
- Revised procedures for CAPA and Investigations
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Mentored junior staff members in best practices for quality management, contributing to overall team growth and development.
Quality Manager – Site Head of Quality
Central Admixture Pharmacy Services (CAPS)
08.2019 - 08.2022
- Company Overview: CAPS is the nation's largest network of outsourcing admixture pharmacies
- Managed and provided oversight of Quality Assurance/Quality Control operations for the CAPS Phoenix503B operations
- Overall responsibility for QC Chemistry, QC Microbiology, QA Process Control, FDA, State Boards of Pharmacy, and third party audits, and product surveillance
- Lead team through successful regulatory and third party audits
- Worked with other CAPS503B sites to harmonize processes for consistency and compliance
- Helped increase production capability compliancy by96%
- Implemented an environmental continuous monitoring (Non-Viable Air sampling and Viable Air sampling) in order to move from shift environmental monitoring to per batch environmental monitoring
- Lead team to implement new chemistry testing equipment in order to perform all release testing on site
- Increased batch sizes which lead to increased volume without increasing headcount in QC Chemistry, QC Microbiology, and QC Process Control
- Actively contributed to maintain site GMP status as No Action Indicated/Voluntary Action Indicated (NAI/VAI)
- Partnered with Operations to ensure compliance with policy and procedure
- Managed root cause analysis investigations, determining underlying issues in product failures and implementing corrective actions as necessary.
- Managed and archived quality documentation and participated in internal and external quality audits.
- Provided training to employees on best practices in quality management, fostering a culture of excellence within the organization.
- Enhanced customer satisfaction by monitoring and addressing customer complaints promptly and efficiently.
Director of Quality Assurance/Regulatory Affairs
Summit Pharmaceuticals
05.2017 - 05.2019
- Company Overview: Summit Pharmaceuticals is an innovative company supplying over the counter (OTC) pharmaceutical products and medical device products
- Managed and provided oversight of the Quality Assurance and Regulatory Affairs operations that included the quality system, FDA and third party audits, international regulatory product applications, international raw material audits, product surveillance, and agency (FDA) communication
- Overhauled the quality system to stream line and enhance quality assurance and blend the demands of pharmaceutical and medical device regulations
- Managed and collaborated to file and received approval for international applications for drug products initiatives
- Led the team through successful third party audits
- Collaborated with manufacturing and operations on creating SOPs both for reduction in errors and compliance
- Reviewed and approved all batch records, incoming raw materials, SOPs, document changes, and customer complaints
- Wrote and executed validation protocol for new equipment and process which included IQ, OQ, and PQ’s along with cleaning validation
- Improved third party audit test scores from a rating of75 to a rating of92
- Overhauled the incoming raw material process along with the retention process to be compliant with cGMP and better usability
- Revamped the manufacturing batch records to capture critical steps and calculations for compliance and on-going statistical analysis to better track quality metrics/quality control
- Actively contributed to maintain site GMP status as No Action Indicated/Voluntary Action Indicated (NAI/VAI)
- Collaborated with manufacturing/operations on retooling the Preventative Maintenance (PM) and Maintenance Program to ensure equipment performed within validated process and continued operation with limited downtime
- Authored documentation for internal use by QA personnel, setting guidelines for review activities and reporting requirements.
- Enhanced product quality by implementing comprehensive quality assurance processes and procedures.
Senior Quality Consultant
Oxford Global Resources
01.2016 - 06.2016
- Company Overview: Oxford Global Resources is the leading provider of information technology, engineering and regulatory & Compliance consultants, project teams, and strategic outsourcing services throughout North America and Europe
- Worked with Client to conduct complex investigations into manufacturing, microbiology, and chemistry deviations
- The investigations include root cause analysis, corrections, and appropriate CAPAs
- Mentored Gilead investigators on investigation/root cause analysis techniques
- Championed a proactive approach to problem-solving, swiftly addressing any potential issues before deviation escalated into larger concerns affecting product integrity or customer perception.
Senior Quality Consultant
Oxford Global Resources
04.2015 - 11.2015
- Worked with Client to successfully reduce deviations open over 30 days and work to reduce initiation to QA approval to 15 days
- Audited deviation system for compliance to FDA and Health Canada regulations
- Implemented changes to the system for ongoing sustainability and drive average closure time to15 days
- Championed a proactive approach to problem-solving, swiftly addressing any potential issues before they escalated into larger concerns affecting product integrity or customer perception.
- Reduced waste in the production process through identification of root causes and implementation of effective solutions.
Consultant
ProPharma Group
09.2014 - 11.2014
- Company Overview: ProPharma Group provides comprehensive, hands-on, compliance services to the pharmaceutical, medical device, biotechnology and dietary supplement industries
- Executed a retrospective review of Annual Product Reviews (APR) for third party manufactured products for FDA remediation
- Identified items in the APRs that require a follow up, assigned follow up action items in the TrackWise system, and completed all required protocol documentation
- Completed project before assigned due date
Principal Consultant
Parexel
01.2014 - 06.2014
- Company Overview: PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies
- Investigation/Deviation investigator team member for a sterile injectable pharmaceutical company
- Performed manufacturing/maintenance investigations and documenting the results of the investigation with root cause determination
- Performed Corrective Action/Preventative Action (CAPA) that address root cause(s) as determined by the investigation/deviation in order to minimize/prevent reoccurrence
- Built strong relationships with clients, fostering long-term partnerships and repeat business.
Principal Consultant
Ben Venue Laboratories
01.2012 - 01.2014
- Investigation Mentoring team member for sterile injectable pharmaceutical company
- Conducted mentoring sessions focusing on QC investigations with Client Investigator, and Quality Sponsor
- Developed lesson plan to guide discussions on investigations
- Reviewed investigation-related documentation requirements, adherence to client procedures, and personnel understanding of job related task and compliance to cGMPs
- Developed and delivered Investigator class-room training curriculum that represents the following areas:
- O Systematic approach on performing and documenting Investigations
- O FDA/Regulatory Agency requirements
- O Tools for Quality Improvement and Effective Investigations
- O Hands-on Training of Quality Tools
- Built strong relationships with clients, fostering long-term partnerships and repeat business.
Deviation and CAPA Specialist
Validant Consulting Services
11.2010 - 01.2012
- Company Overview: Validant is a hybrid professional services firm that provides Medical Device, Pharmaceutical and Biotechnology companies with the resources that they need to meet the unique challenges of FDA regulated industry
- Performed process deviation investigations, root cause analysis, CAPA(s), and reported on findings
- Numerous investigations led to the identification, development and implementation of CAPA(s)
- The investigations addressed issues within aseptic and sterile filling and finishing, solutions prep, sterilizers, commodities (syringes, vials, flex bags, cappers, etc.), laboratories (biological and chemical), environmental and instrumentation
- Followed all company policies and procedures to deliver quality work.
Quality Assurance Associate
WL Gore and Associates
01.2008 - 01.2010
- Company Overview: Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork
- Managed a broad range of responsibilities as a member of the Interventional Medical Products Quality Assurance team
- Worked on cross-functional teams to address product issues, define and implement effective corrective actions and monitor post-implementation effectiveness
- Worked with Product Surveillance associates in reviewing and approving product complaints
- Confirmed compliant and MDR reportability and completeness of the investigation within internal procedure(s) and external FDA/International standards and guidelines
- Involved in operational improvements, product development and design control activities, systems enhancement (including software implementation and validation), compliance auditing, vendor selection/approval, and associate training
- Reviewed and approved all manufacturing deviations
- Prepared and communicated quality reports
Quality Assurance Manager – Manufacturing
Watson Pharmaceutical, Inc.
02.2000 - 01.2007
- Company Overview: A leading specialty pharmaceutical company that develops, manufactures, markets, and distributes brand and generic pharmaceutical products
- Managed Quality Assurance Supervisors and Quality Assurance Inspectors with the responsibilities of overseeing adherence to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP’s) in the incoming, sterile fill, manufacturing services, packaging and release operations
- Helped led the facility through a Consent Decree remediation which was subsequently removed five and a half years after it was issued
- Reviewed and approved all manufacturing deviations, change controls, protocols, and test plans
- Coordinated all regulatory audits by ensuring timely retrieval of documentation and prepping subject matter experts prior to interviews with the agency
- Performed all budgeting activities for Quality Assurance
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
- Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization.
Quality Assurance Supervisor – Manufacturing
Watson Pharmaceutical, Inc.
12.1998 - 01.2000
Training Specialist
Watson Pharmaceutical, Inc.
11.1998 - 12.1998
Sterile Fill Supervisor
Watson Pharmaceutical, Inc.
04.1998 - 10.1998
Documentation Review Specialist I, Quality Assurance
Watson Pharmaceutical, Inc.
03.1997 - 04.1998
Compounder II, Manufacturing Services
Watson Pharmaceutical, Inc.
02.1993 - 03.1997
Education
Some College (No Degree) - Courses Completed in Finance
Northern Arizona University
Flagstaff, AZThe Basic Industrial Course in the Preparation of Parenteral Medications
University of Tennessee, Memphis
Memphis, TNSkills
- Training and mentoring
- Quality control guidelines
- Written and oral communication
- Quality management systems
- Internal auditing
- Compliance monitoring
- Corrective actions
- SOP development
- Quality assurance management
- Quality assurance methodologies
- Problem-solving abilities
- Documentation review
Timeline
Produce Associate 1
Sam’s Club
08.2023 - Current
Quality Assurance Manager
BioLab Sciences
10.2022 - 12.2022
Quality Manager – Site Head of Quality
Central Admixture Pharmacy Services (CAPS)
08.2019 - 08.2022
Director of Quality Assurance/Regulatory Affairs
Summit Pharmaceuticals
05.2017 - 05.2019
Senior Quality Consultant
Oxford Global Resources
01.2016 - 06.2016
Senior Quality Consultant
Oxford Global Resources
04.2015 - 11.2015
Consultant
ProPharma Group
09.2014 - 11.2014
Principal Consultant
Parexel
01.2014 - 06.2014
Principal Consultant
Ben Venue Laboratories
01.2012 - 01.2014
Deviation and CAPA Specialist
Validant Consulting Services
11.2010 - 01.2012
Quality Assurance Associate
WL Gore and Associates
01.2008 - 01.2010
Quality Assurance Manager – Manufacturing
Watson Pharmaceutical, Inc.
02.2000 - 01.2007
Quality Assurance Supervisor – Manufacturing
Watson Pharmaceutical, Inc.
12.1998 - 01.2000
Training Specialist
Watson Pharmaceutical, Inc.
11.1998 - 12.1998
Sterile Fill Supervisor
Watson Pharmaceutical, Inc.
04.1998 - 10.1998
Documentation Review Specialist I, Quality Assurance
Watson Pharmaceutical, Inc.
03.1997 - 04.1998
Compounder II, Manufacturing Services
Watson Pharmaceutical, Inc.
02.1993 - 03.1997
Some College (No Degree) - Courses Completed in Finance
Northern Arizona University
The Basic Industrial Course in the Preparation of Parenteral Medications
University of Tennessee, Memphis
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