Kimberly Ketcham

Experience

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  Hoechst AG

  Apr 1996 - Dec 1997

  Quality Assurance Microbiologist

  Microbiologist responsible for testing and releasing raw materials and finished products within a pharmaceutical facility. Performed environmental monitoring of sterile and non-sterile production and testing areas. Formally maintained the Package Integrity program for products from three production facilitiesKey Responsibilities and Achievements: • Maintained working, stock and frozen cultures of various bacteria and fungi • Experienced in USP microbial limits testing and product stability testing• Skilled in LAL testing, finished product sterility testing, preservative efficacy testing and package integrity testing Show less

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  Schering-Plough Research Institute

  Dec 1997 - Sept 2000

  Assistant Scientist II, Chemotherapy & Molecular Genetics

  Scientists responsible for drug trial in-vivo and in-vitro efficacy studies. Performed various fungal and bacterial studies for drug susceptibility testing in vitro. Skilled in IP, SC, IV, and IT in vivo routes of infection and IP, SC, and PO in vivo routes of drug administration in mice. Skilled in drug efficacy testing using organ retrieval methods from infected and treated mice. Key Responsibilities and Achievements: Genetic sequencing for multiple strains of Staphylococcus species within mixed clinical cultures to isolate possible areas of drug resistances.• Maintaining working, stock and frozen cultures of various bacteria, yeast, and mold • Researched and authored a protocol to evaluate b-glucuronidase enzyme activity for in-house bacterial strains by using 4-methylumbelliferyl-b-D-glucuronide (MUG) agar Show less

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  Elan Pharmaceuticals

  Oct 2000 - Jun 2002

  Sr. Microbiologist

  Supervisor for the QC Microbiology Laboratory with additional people management responsibilities for two laboratory technicians. Served as a member of the Management team that determined the daily operating schedule for the facility.Key Responsibilities and Achievements: Authored SOPs to support Microbiology functions and laboratory compliance. Developed and maintained a structured training program for all personnel working in a classified (Class 100 – 100,000) environment. Maintained the Environmental Monitoring and Media Fill programs. Responsible for environmental monitoring of sterile and non-sterile manufacturing areas. Responsible for validation of Autoclave, Oven, and Lyophilizer used in the manufacturing of sterile lyophilized parenteral. Show less

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  Convatec

  Jul 2002 - Aug 2006

  Established appropriate programs, policies, and procedures to put in place and maintain appropriate QMS compliance for the company’s third-party manufacturing in line with FDA requirements. Key Responsibilities and Achievements: Facilitating external Regulatory Inspections including FDA. Managing responses to External Regulatory Agencies. Performing monthly internal audits to determine the adherence to new and amended procedures within the sites. Providing Quality Reports to the Compliance Review Board including compliance metrics for Internal Audits, Complaint Handling Process and Document Control. Enhanced broad compliance knowledge to support additional areas including GCP (Good Clinical Practices) and EHS (Environmental Health and Safety) • Strong understanding of 21 CFR 210, 211, 803 & 820 • Created a new process for medical device reporting (specific for the US) which defined how to comply with reporting requirements in 21 CFR Part 803, investigation requirements in 21 CFR Part 820.198 (d) and incorporated clinical trial materials as well as marketed products Show less Position held until an internal promotion to Senior Compliance Assurance AuditorKey Responsibilities and Achievements: Ensured that the third-party manufacturers followed and met all quality procedures and standards. Managed and directed Quality Assurance for contract manufactured products. Developed formal Quality Agreements for new and existing Contract Manufacturers that included metrics to monitor performance in Quality. Auditing Contract Manufacturers against Industry Regulations and ConvaTec policies. Developed a change control communication process with contract manufactures that ensured agreement between the supplier and ConvaTec prior to implementation of changes • Lead a diverse team and developed a Global Guideline for External Supplier Evaluation implemented globally as a tool during the Supplier selection process Show less

  • Sr Compliance Assurance Auditor

    Jun 2005 - Aug 2006

  • Sr Quality Assurance Specialist

    Jul 2002 - May 2005
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  Dsm-firmenich

  Jan 2012 - now

  Director level position overseeing all aspects of the organization's quality management system to include developing, implementing, and maintaining policies, procedures, and training. Leading GMP compliance in a regulated industry, complying with both domestic and international standards. Key Responsibilities and Achievements: I have built a high performing Quality Team with a strategic focus on continuous quality improvement. I led an initiative to reduce the overall testing cost by 20% and improved lead time by 47% for product release and serving the customer. Year over year, I have provided quality leadership while implementing strategic business initiatives. I lead all customer and regulatory inspections for the site. I am certified in the Apollo method for Root Cause Analysis. With this certification, I have been instrumental in the timely identification and correction of quality incidents. I developed a tool using Power BI to give a visual representation of key quality performance indicators to drive improvements across all Quality Systems. In addition to leading a site Quality team, I have been the global quality contact for a high-profile strategic customer. In this role, I have gained international experience in managing quality incidents and working directly with infant formula manufactures.• Strong knowledge of regulations: 21 CFR 110, 111, 117 • Strong knowledge of standards; ISO 9001, ISO 14001, ISO 22000, FSSC 22000, FEMAS, FAMI-QS• Recipient of ‘Supplier Quality Recognition Award’ for having and excellent performance in Quality and Food Safety• Awarded “Best in Class” by customers for driving an IF Quality Culture, HACCP plans, and Management of Change• Leading a team of 25 Managers, Officers, and Analysts while managing 6 direct reports. Show less Position held until an internal promotion to Senior Manager, Quality Investigated customer complaints to provide appropriate responses to customers in a timely manner. Created and implemented cross functional team to review all complaints on a monthly basis and implement corrections to improve products for all customers. Initiated qualification and validation process for the site. Site lead for North American regional harmonization of quality documents, SAP implementation, and TrackWise implementation.Key Achievements/Contributions:● Deployed TrackWise, Documentum, SAP, and integrated the site into key global digital QMS tools. ● Founded the Complaint Resolution Team (CRT) to uncover/implement CAPAs related to customer complaints.● Developed program to drive quality culture and improve existing quality standards. Show less

  • Customer Champion (Medical Nutrition and Early Life Nutrition) HNC Global Quality

    Mar 2024 - now

  • Senior Manager Quality

    Dec 2015 - Mar 2024

  • Manager - Technical Quality

    Sept 2012 - Dec 2015

  • Quality Release Specialist

    Jan 2012 - Sept 2012