David Mayer
Olathe
Summary
Highly motivated and detail oriented Quality Professional with 13 years of human pharmaceutical and animal health experience. Proven track record of delivering high quality results in fast paced environments with strong abilities in problem solving, and team collaboration.
Overview
14
14
years of professional experience
Work History
Global 3rd Party QA Specialist
Ceva Animal Health
01.2024 - Current
- Perform external audits for Ceva activities ensuring the preparation of complete, concise and timely investigated reports
- Ensure CAPA, change control activities are followed-up and closed out properly
- Perform qualifying and oversight audits of CMOs who manufacture, package, and test EPA, FDA veterinary pharmaceutical products or products with other applicable regulations or guidelines
- Develop and manage a system to ensure all quality investigations and audit deficiencies are properly abated
- Receive CMO related complaints, evaluating them as product quality defects, supply chain
- Responsible for investigations with CMO into product diversion and related issues
- Under limited supervision, implement and administer a Standard Operating Procedures (“SOP”) program aligned to proper regulatory and business practice requirements
- Write and/or edit SOPs pertaining to the Quality Assurance responsibilities and duties
- Ensure consistency and appropriate storage of documents
- Write Quality Agreements for CMOs. Review and approve critical GMP documents from the CMO (e.g. MBR, specifications)
- Receive notification of Quality Issues from contractors; assess the risk to Ceva, communicate risk factors to Ceva management. Develop appropriate risk management strategies
- Work with contractors to investigate Quality issues, assess root cause and develop effective CAPA; plan and coordinate annual quality meetings with critical contractors
- Develop Key Quality Performance Indicators for Ceva contractors; define with contractors metrics on their KPIs and communicate them to Ceva management
- Review product annual reports and investigational information for regulatory compliance and quality risk
- Provide regulatory guidance and expertise
Quality Assurance Manager
Centaur Animal Health
06.2023 - 12.2023
- Oversee and manage Quality and Regulatory processes within a FDA/DEA/DHS licensed Pharmaceutical Manufacturing facility
- Conduct cGMP, GLP and OSHA training for all employees
- Handle all document control processes which includes, batch records, labels, raw materials, packaging, SOP’s, deviations, CAPA’s and other internal compliance records
- Perform laboratory and production audits
- Control design and review of customer label builds and registration processes
- Lead and conduct weekly SQDCP meetings with management and quality team
- Assist in laboratory and production validation processes
Data Review Specialist
KCAS
10.2022 - 05.2023
- Responsibly sign off on all data (100% review of all lab generated data and solution preparation including Excel spreadsheets, report tables, transmittals, outliers and repeated samples testing, sample inventories).
- Review final client reports and associated documents.
- Proficient in lab software (Analyst and Watson).
- Capable of making minor changes in LIMs software.
- Generate SOPs or policies in applicable areas as required.
- Archive data as needed.
QA Specialist
Catalent Pharma Solutions
08.2017 - 10.2022
- Performs laboratory data audit and data verification
- Laboratory facility audits
- Review, approval and issuance of Certificates of Analysis (CofA), and Analytical Result Forms (ARF)
- Audit of Stability and Technical Reports
- Review and approval of analytical methods, specifications, and protocols
- Method validation and method transfer audits
- Ensures that products tested according to applicable FDA guidelines, regulations GXPS and internal SOPs
- Follow GXP (e.g. GMP, GDP, etc) as necessary to accomplish daily tasks
- Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines
- Perform tasks according to “standard work” as defined by Manager
- Perform additional tasks as assigned by Manager
- Meets deadlines according to agreed timeframes and communicates adjustments as needed
Senior Associate Scientist
Catalent Pharma Solutions
10.2014 - 08.2017
- Perform dissolution testing on release and stability samples
- Interacted with clients to initiate and support projects
- Aid in dissolution method development, method transfer, and method validation
- Support DOE studies of drug product
- Perform analysis by HPLC and UV/VIS
- Adhere to cGMP principles by following internal SOP’s and methodologies
- Assured the integrity and quality of analytical data are produced by adhering to all relevant SOPs, methods and regulatory requirements
- Follow Good Documentation Practices
- Work with QA and analysts to resolve investigations/deviations/out-of-trend results
Chemist
Acceleration Laboratory Services, Inc.
06.2012 - 10.2014
- With a moderate level of guidance, conducts experiments in the laboratory and generate data or other information under GLP and GMP conditions
- Provides some assistance with the design of appropriate laboratory experiments (e.g. analytical method development and validation)
- Operates, maintains, and calibrates all job-relevant instrumentation and equipment as necessary
- Responsible for accurately recording data and observations, calculations, and reporting of data
- Ensures proper documentation of all activities involving samples, standards, controlled substances, and stability samples associated with Acceleration projects as dictated by GLPs and cGMPs
- Conducts all activities in a safe and professional manner consistent with corporate and department policies, procedures, SOPs, GLPs and GMPs
- Notifies management about issues, problems, deviations, corrective actions, potential efficiency improvements, etc
- Ensures general laboratory or work area cleanliness
- Projects a positive image of Acceleration in the community
- Manages projects so that they meet the stated objectives in the stated time
- Other duties as assigned
Laboratory Technician
United States Geological Survey
03.2011 - 05.2012
- Preform daily solid phase extractions including LCEA, LCPD, LCHM, LCGY, and LCAB
- Preform GCG solid phase micro extractions
- Assist in data analysis
- Preform lab clean up and maintenance
- Student Position
Education
Bachelors of Science - Biochemistry
University of Kansas
05.2012
Skills
- Internal and external auditing
- FDA Compliance
- GMP
- CAPA (Corrective and Preventive Actions)
- Root Cause Analysis
- Deviation Management
- Change Control Management
- SOP Development and Review
Timeline
Global 3rd Party QA Specialist
Ceva Animal Health
01.2024 - Current
Quality Assurance Manager
Centaur Animal Health
06.2023 - 12.2023
Data Review Specialist
KCAS
10.2022 - 05.2023
QA Specialist
Catalent Pharma Solutions
08.2017 - 10.2022
Senior Associate Scientist
Catalent Pharma Solutions
10.2014 - 08.2017
Chemist
Acceleration Laboratory Services, Inc.
06.2012 - 10.2014
Laboratory Technician
United States Geological Survey
03.2011 - 05.2012
Bachelors of Science - Biochemistry
University of Kansas
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