Summary
Overview
Work History
Education
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Timeline
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OfficeManager
Kris Williamson

Kris Williamson

Quality
Riverview,FL

Summary

Quality Assurance, Quality Control, Quality Systems/Compliance, Sterility Assurance and Sterilization executive with over 14 years of extensive experience in designing, enhancing, restructuring and remediating compliance related issues within the Biologics, Pharmaceutical, Biotechnology and Medical Device industries.

Quality Assurance, Quality Control, Quality Systems/Compliance, Sterility Assurance and Sterilization executive with over 14+ years of extensive experience in designing, enhancing, restructuring and remediating compliance related issues within the Biologics, Pharmaceutical, Biotechnology and Medical Device industries. Quality Systems Subject Matter Expert (SME) with a proven and successful track record and skills in handling routine or difficult and complex quality related compliance issues and remediation, FDA Form 483’s, Warning Letters and Consent Decree issues.

Overview

20
20
years of professional experience

Work History

Director of Quality

Williamson Consulting Inc
01.2012 - Current
  • Supports various clients manufacturing operations from clinical phase through commercialization and also performs routine and difficult to handle FDA and International Regulatory Bodies' Quality and Compliance, FDA Form 483, Warning Letter and Consent Decree Remediation support work
  • Consulting expertise is not limited to, Pharmaceutical, Biotechnology, Medical Device, and Biologic product support from start up through routine support and stabilization of the production processes.
  • Championed lean manufacturing initiatives, driving waste reduction efforts and increasing operational efficiency across the organization.
  • Reviewed technical documentation for accuracy and completeness, reducing potential errors in product specifications or assembly instructions.
  • Directed risk assessment activities during product development phases to prevent potential issues from escalating into costly recalls or lawsuits later down the line.
  • Collaborated with suppliers to enhance their understanding of our quality requirements, fostering strong relationships built on trust and transparency.
  • Improved overall product quality by implementing robust testing methodologies and streamlining process improvements.
  • Established clear performance metrics, monitoring progress to ensure continuous improvement in product quality and customer satisfaction.
  • Implemented a robust supplier management program, ensuring alignment with company goals while mitigating supply chain risks.
  • Led a cross-functional team to develop and execute comprehensive quality assurance plans for products and services.
  • Developed training programs that enhanced employees'' understanding of quality standards, leading to improved production accuracy and efficiency.
  • Managed external audits, maintaining compliance with industry regulations and achieving certification renewals without interruptions.
  • Ensured adherence to ISO 9001 standards throughout all processes, reinforcing a company-wide commitment to quality excellence.
  • Streamlined internal audit procedures by developing standardized templates for reporting findings efficiently and consistently.
  • Championed the adoption of automated quality control systems, reducing human error while increasing efficiency in identifying potential defects.
  • Built strong partnerships with key stakeholders, enabling increased collaboration on problem-solving efforts and overall process improvements.
  • Drove root cause analysis investigations for customer complaints, implementing corrective actions that reduced recurrence rates and improved client retention.
  • Directed quality assurance teams, shortened validation turnaround times and reduced customer complaints.
  • Authored documentation for internal use by QA personnel, setting guidelines for review activities and reporting requirements.
  • Oversaw QA operational activities such as sampling, inspection and line monitoring, verifying compliance with prescribed fault rates and tolerance goals.
  • Drafted internal QA policies on factors such as design controls, product realization activities, validation techniques and more.
  • Interfaced directly with high-level executives within client companies, addressing concerns and correcting perceived faults to maintain smooth customer relationships.
  • Established and tracked quality department goals and objectives.
  • Determined quality department standards, practices, and procedures.
  • Applied coaching techniques and tools to support managers and team members in improving performance.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Project for Paklab- Served as Quality Consultant to increase compliance with regulatory bodies’ ensuring accuracy and streamlining of processes assisted in FDA responses related to 483 observations, gap assessment, risk assessment, and employee coaching
  • Project for QuVa Pharma- Independent Auditor
  • Project for BioNTec - EU Inspection successful completion of Turkish authority and successful award of the European GMP certificate April 2024 May 2024
  • Project For CAPS – 483 remediation projects within a 503b regulated facility as the principle consultant and Batch release
  • Project for BEO Pharmaceuticals- Gap assessment consultant for FDA readiness
  • Project for Fujifilm-SAP implementation, consultant technical writer
  • Project for IFF- Microbiology advisor for new product implemeentation
  • Project for Denison Pharmaceuticals- remediation responses for system suitability of BioLumix System Validation
  • Project Smiles Direct- Microbiology advisor for Dental Puddy Jan 2023- Feb 2023
  • Project for CSL Behring- Person in plant for product fills March 2022 -Jan 2023
  • Project for Qualgen- 483 remediation projects within a 503b regulated facility as the principle consultant July 2022 -March 2023
  • Project for ATARA-EU Inspection successful completion over two manufacturing site and successful award of the European GMP certificate July 2022
  • Project for Cognate/Atara- FDA readiness, Prepared Cognate and Atara for FDA inspection and BLA submission. Oct 2020-Sep 2021
  • Project Toyobo- Microbiology SME for gap assessment and batch Certification.
  • Project for Mallinckrodt / Stratatech- Enhanced the EM program consulted client with BLA submission on Microbiology side of things.
  • Project for Pfizer IKKT -Successfully completed laboratory observation project as part of 483 remediation Jan 2019
  • Project for Edge Pharma– Successfully completed 483 remediation projects within a 503b regulated facility as the principle consultant Jul 2018
  • Project for Polpharma- Successfully completed New Lab creation and Qualification project for Microbiology, Chemistry and cell biology labs in all aspects including but not limited to the Lab design, personnel planning, equipment URS creation, and equipment accession as the principle consultant Oct 2017 April 2018
  • Project for Kimberly clark– Successfully completed Laboratory remediation project as the principle consultant Nov 2016 -Oct 2017
  • Project for SAFC – Successfully completed validation of a newly established cleanrooms as validation consultant July 2015 -Nov 2016
  • Project for Pharmadax – Successfully completed laboratory audit as the principle Microbiology expert June 2014-June 2016
  • Project for Emcure – Successfully completed Batch record assessment as the principle Microbiology expert April 2013 – May 2014
  • Project for Kedrion – Qualified new aseptic fill facility. March 2013 - April 2013
  • Project for Sanofi pasture – Successfully completed a Gap assessment project supporting data integrity document review and remediation effort Jan 2013-March 2013.
  • Project OSObio- Successfully completed a Gap assessment and Microbiological compliance Jan 2013.
  • Project for Hospira- Supported a Document compliance review Jan 2012- Jan 2013


Director of Quality

Aldevron
03.2023 - 06.2024
  • Aseptic Processing Consultancy and Support
  • Clients and Successful Projects: Currently provide support to several high profile fortune 100 clients with projects within Cell Therapy, Medical Device, Pharmaceuticals Operations such as follows:
  • Championed lean manufacturing initiatives, driving waste reduction efforts and increasing operational efficiency across the organization.
  • Reviewed technical documentation for accuracy and completeness, reducing potential errors in product specifications or assembly instructions.
  • Directed risk assessment activities during product development phases to prevent potential issues from escalating into costly recalls or lawsuits later down the line.
  • Improved overall product quality by implementing robust testing methodologies and streamlining process improvements.
  • Established clear performance metrics, monitoring progress to ensure continuous improvement in product quality and customer satisfaction.
  • Led a cross-functional team to develop and execute comprehensive quality assurance plans for products and services.
  • Managed external audits, maintaining compliance with industry regulations and achieving certification renewals without interruptions.
  • Spearheaded Six Sigma initiatives across multiple departments, measurably improving process efficiencies throughout the organization.
  • Championed the adoption of automated quality control systems, reducing human error while increasing efficiency in identifying potential defects.

Global Quality Assurance Manager

Lucira Health
01.2023 - 02.2023
  • Improved throughputs by 80% for quality labs and reduced non-conformances by 25% across all sites
  • Maintained up-to-date knowledge on industry trends and regulations, ensuring accurate advice was provided to clients at all times.
  • Developed long-lasting relationships with clients to ensure consistent retention and loyalty.
  • Managed risk effectively by closely monitoring client portfolios and making timely adjustments.
  • Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization.
  • 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.
  • Enhanced product quality by implementing comprehensive QA processes and procedures.
  • Mentored junior staff members in best practices for quality management, contributing to overall team growth and development.
  • Assured consistent quality of production by implementing and enforcing automated practice systems.
  • Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
  • Performed root cause analysis to identify and resolve quality issues and defects.
  • Reduced defects in products by conducting thorough inspections and identifying areas for improvement.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
  • Streamlined testing processes by introducing automated tools, increasing efficiency and reducing errors.
  • Collaborated with cross-functional teams to identify root causes of product issues, leading to timely resolutions and continuous improvements.

Microbiology Subject Mater Expert

B.Braun
07.2010 - 01.2012
  • Completed Sterility program implementation
  • (SME) Consultant for Manufacturing Operations, Quality Systems, Compliance, Quality Control, Sterility Assurance, Sterilization, Microbiology and Contamination Control
  • Supports clients with Biologics, Medical Device, Pharmaceutical, and Biotechnology products
  • Supports clients with cGMP, cGCP, cGLP, cGDP and cGTP regulated product manufacturing, testing, and control to meet applicable national and international regulations
  • Develops, enhances, supports and redefines a client’s Product Compliance/Quality Systems, manufacturing processes, Quality Control testing and controls
  • Establishes, enhances, design and support Quality Systems investigations programs such as CAPA, Supplier Corrective Action Report (SCAR), OOS, Deviation, Product Non-conformance, and Failure investigation for compliance
  • OOS, Failure, Product Complaint, and Deviation investigations such as Trackwise, LIMS, etc
  • To ensure compliance to 21 CFR Part 210 and 211
  • Performs product impact and risk assessment, resolution, recommendation and closure of quality investigations in a timely manner
  • Provides a routine trend report of quality related investigation to management ensure corrective action effectiveness
  • Mentored junior team members, contributing to their professional growth and development.
  • Established best practices for knowledge sharing, fostering a culture of continuous learning and improvement.
  • Developed effective training materials for diverse audiences, resulting in improved skillsets and increased job satisfaction.
  • Streamlined processes to increase efficiency, enabling teams to complete tasks ahead of schedule.
  • Managed complex projects from inception through completion, delivering high-quality results within tight deadlines.
  • Served as a liaison between technical experts and business stakeholders to ensure alignment on project objectives and deliverables.
  • Optimized subject matter content by conducting extensive research and incorporating industry trends.
  • Installed, configured, and monitored new system features based on user needs.
  • Conducted in-depth research to stay ahead of industry trends, ensuring company's solutions remained competitive.
  • Streamlined communication between departments, ensuring that project specifications were clearly understood and met.

Microbiology Expert

Vetter Development
11.2009 - 07.2010
  • Performed in less than one year, a complete and aggressive overhaul of the Vetter Quality/QC Microbiology lab operations from German location
  • This is not limited to a full gap analysis of the previous Quality/Microbiology Systems, procedures and practices
  • Lead reorganization, procedural changes, additions as well as while transfering the labs procedures and, processes and Quality Systems to meet the current industry US standards
  • Wrote many new Quality/Microbiology procedures to ensure that the systems and procedures are fully operational, compliant in order to meet the requirements of different regulatory guidelines by performing a gap analysis of all procedures and closing the gaps as found
  • Also performed a gap analysis of the test methods and equipment used in the labs and performed equipment and test method validation where required
  • Established new in-house tests methods (MicroSeq and Vitek Compact II) for Microbial Identification which helped improve the Micro ID results which in turn aided and improved Environmental Monitoring investigations
  • Managed the entire Environmental Monitoring program not limited to the EM sampling procedures, incubation, data review for compliance, EM investigations, corrective action program, room remediation, and trend report writing
  • Managed several Microbiologist with direct management of the technicians charged with performing Environmental Monitoring, Equipment Validation/Qualifications, Audit/Compliance, Microbial identification, LAL testing, Gas Monitoring, Bioburden testing and Biocompatibility testing
  • Managed the entire Cleanrooms within the production areas for ISO 7, ISO 8 and ISO 9 cleanrooms Performs a review of the facility validation protocols and reports specific to providing the required guidance, specifications for EM sites selection, sampling types, acceptance criteria and room specifications
  • Work with Facility Engineering on cleanroom design, Basis of Design, User Requirement Specification, and room parameters not limited to setting the specification for the differential pressure, temperature, humidity and air exchange requirements to be compliant with the FDA, ISO guidelines
  • Worked as a team with the Facility Validation department to help in the restructure of the Facility validation and Cleaning Validation efforts including the protocols, reports and how data are presented which has aided in successful audit results and commendation from outside agencies
  • Modified the Facility’s Cleanroom practices and contamination control methods in support of changes to the production processes
  • Facilitated Facility’s disinfectant efficacy (DE Study) studies to validate all disinfectants used at the different sites
  • Managed the Environmental Monitoring Program and Investigation processes, Product Non-conformance reporting (NCMR), Product out of Specification (OOS), Corrective and Preventative Action (CAPA) processes for all products and processes to include the quarterly CAPA and Environmental Excursion Report and Environmental Trend reports as applicable
  • Worked as a team to revamp the Document Control systems in areas of procedural changes to the document processing systems
  • Worked as a team with the Supplier Quality department with regards to providing technical expertise in areas of approving new or existing vendor/supplier, contract laboratory or test laboratory qualification and re-qualification
  • Worked with teams on projects on cleanroom design, BOD, URS, FRS etc to ensure that the best in class in cleanroom design is adopted and implemented
  • Worked with the Quality Assurance Release management in areas of product testing documentation, disposition, sterilization load release and routine product release functions
  • Propelled the Quality Systems/Microbiology group to achieve a successful Pre-approval Inspection of the new product without a single 483
  • Responsible for budgets, and other duties for the Quality Control department
  • Accountable for determining product test strategy, as well as writing corresponding test plans and protocols for Quality Control testing.
  • Self-motivated, with a strong sense of personal responsibility.
  • Worked effectively in fast-paced environments.
  • Skilled at working independently and collaboratively in a team environment.
  • Proven ability to learn quickly and adapt to new situations.
  • Worked well in a team setting, providing support and guidance.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Organized and detail-oriented with a strong work ethic.

Quality manager

Sentry Manufacturing
04.2008 - 07.2009
  • Created Quality Program and Lab
  • 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.
  • Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters.
  • Conducted thorough audits to ensure adherence to industry standards and regulatory requirements, maintaining compliance consistently.
  • Evaluated quality problems and performed assessments to identify and resolve issues.
  • Mentored and encouraged employees to strive for excellence while fostering professional growth.
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Provided training to employees on best practices in quality management, fostering a culture of excellence within the organization.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.
  • Improved quality processes for increased efficiency and effectiveness.
  • Streamlined production processes by identifying areas for improvement and implementing corrective actions.

Microbiologist

Azopharma
10.2007 - 02.2008
  • I was recruited to support the Quality Control laboratory in its function as CLO and CMO
  • Worked with specific functions within the organization to specifically comply with the requirements of 21 CFR on Building and Facilities, Equipment, Control of Components and Drug Product Container and Closures, Production and Process Controls, Packaging and Label Control, Holding and Distribution, Laboratory Controls, and Records and Reports requirements.
  • Scheduled and trained technical staff members.
  • Reduced contamination risk by maintaining a sterile laboratory environment and adhering to safety protocols.
  • Provided technical support for the implementation of cutting-edge molecular diagnostic tools such as PCR analyses.
  • Collected and processed specimens for clinical protocols.
  • Kept accurate databases of specimens collected and stored in repository.
  • Optimized lab workflow by training junior staff members on proper equipment usage, sample handling, and data recording practices.
  • Improved quality control measures by identifying areas of improvement in sample handling and storage processes.
  • Interpreted research findings and summarized data into reports.
  • Ordered laboratory equipment and supplies.

Microbiologist Superviser

Belcher pharmaceuticals
05.2005 - 10.2007
  • Belcher Pharmaceuticals is a generic solid and liquid dose manufacture
  • Performed several Quality Control SME functions within the organization
  • Managed a high volume of Microbiology assay’s in the day to day functions within the facility not limited to product testing and release as applicable.
  • Reduced contamination risk by maintaining a sterile laboratory environment and adhering to safety protocols.
  • Scheduled and trained technical staff members.
  • Collected and processed specimens for clinical protocols.
  • Kept accurate databases of specimens collected and stored in repository.
  • Optimized lab workflow by training junior staff members on proper equipment usage, sample handling, and data recording practices.
  • Improved quality control measures by identifying areas of improvement in sample handling and storage processes.
  • Interpreted research findings and summarized data into reports.
  • Ordered laboratory equipment and supplies.
  • Ensured compliance with regulatory standards by maintaining detailed records of laboratory procedures and results.
  • Designed and executed robust experiments to investigate the effects of various environmental factors on microbial growth patterns.
  • Managed overall laboratory functions.
  • Increased accuracy of test results through meticulous attention to detail during data analysis and interpretation.
  • Assisted in the development of new laboratory protocols, resulting in increased efficiency and cost savings.
  • Conducted routine environmental monitoring surveys to assess microbial presence in manufacturing facilities, ensuring product safety and quality control.

Education

Bachelor of Science - Biology

Concordia University
Seward, NE

Masters - Business Administration

Concordia University
Chicago, IL

Skills

  • Quality Control
  • Microbiology Release Testing
  • Bioburden
  • Sterility Test
  • Growth Promotion
  • Materials Control
  • Microbial Identification
  • Bacteria Endotoxin
  • Biological Indicators Testing
  • Potency Assays
  • Identity testing
  • Tissue Culture Assay
  • PH
  • Sterilization (EtO & Ebeam)
  • Biocompatibility Testing
  • Kinetic LAL Testing
  • ELX 808 Plate Reader
  • ELISA
  • HPLC
  • Steritest
  • MilliflexTM
  • Vitek Compact II
  • MicroSeq DNA Sequencing Equipment
  • Sterilizers
  • Laboratory Information Management System (LIMS)
  • Quality Systems/CAPA Investigation (Trackwise)
  • Training Automated System (IsoTrain)
  • Document Control Systems (Documentum)
  • Corrective Action and Preventative Action Program (CAPA)
  • Out of Specification (OOS)
  • Invalid Assay
  • Sterility Failure
  • Product Failure/Non-conformance
  • Complaint
  • Deviation
  • Departure from QC Procedures
  • Environmental Monitoring Excursion Investigation
  • Aseptic manufacturing requirements
  • Manufacturing process
  • Production and process controls for biologics
  • Quality and Technical Audit
  • Management of Contract Testing Laboratory
  • Supplier/Vendors
  • CRO’s
  • CMO routine and qualification audits
  • Process and quality systems review
  • Routine evaluation
  • Investigations and management for Biologics
  • Pharmaceutical
  • Biotechnology
  • Cell Therapy
  • Medical Device Products
  • CGMP
  • CGCP
  • CGDP
  • CGTP
  • CGLP
  • CGMP Training
  • Aseptic processes
  • Routine Laboratory Methods and Processes
  • Training in Preparation for Pre-approval
  • Post Approval
  • Routine Agency Audits and Inspections
  • Quality Systems/Quality Control Subject Matter Expert (SME)
  • Compliance
  • Sterility Assurance
  • Sterilization processes and regulations
  • Quality Systems and Testing Laboratory Restructuring and Reorganization
  • Technical Writing
  • Standard Operating Procedures (SOP)
  • Validation Protocols and Reports
  • Standard Test Methods (STM’s) Writing and Revision
  • Validation
  • Test Method Validation
  • Facility Validation
  • Manufacturing Process Validation
  • Cleaning Validation
  • Equipment Validation
  • Quality Assurance Record Reviews/Approval Requirement
  • Product Release
  • Batch Record Review
  • Product Non-conformance
  • Test methods
  • Regulatory compliance
  • Risk assessment

Affiliations

  • American Society for Microbiology
  • American Association of Pharmaceutical Scientists
  • American College of Healthcare Executive
  • Society for Industrial Microbiology and Biotechnology
  • National Association of Underwater Instructors
  • Professional Association of Scuba Divers
  • Technical Diving International

Languages

English
Native or Bilingual
German
Native or Bilingual
Spanish
Limited Working

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Director of Quality

Aldevron
03.2023 - 06.2024

Global Quality Assurance Manager

Lucira Health
01.2023 - 02.2023

Director of Quality

Williamson Consulting Inc
01.2012 - Current

Microbiology Subject Mater Expert

B.Braun
07.2010 - 01.2012

Microbiology Expert

Vetter Development
11.2009 - 07.2010

Quality manager

Sentry Manufacturing
04.2008 - 07.2009

Microbiologist

Azopharma
10.2007 - 02.2008

Microbiologist Superviser

Belcher pharmaceuticals
05.2005 - 10.2007

Masters - Business Administration

Concordia University

Bachelor of Science - Biology

Concordia University

Interests

Scuba

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