MARJORIE MANNING
Kansas City,MO
Summary
Quality Assurance Manager and QMS Consultant with over 25 years of experience in biotech and manufacturing, including over 8 years of direct cGMP expertise. Proven track record of leading successful FDA, ISO, and Organic (QAI) audits and inspections. Subject matter expert in the full CAPA lifecycle, trend analysis, and inbound material quality release. Expert in modernizing document control systems, and enforcing strict revision control to ensure 100% regulatory compliance, and audit readiness.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
CERTIFIED SAFETY MANUFACTURING
Kansas City, MO
04.2024 - Current
- Regulatory Leadership: Direct site readiness and lead participation for FDA audits, ensuring all quality systems and manufacturing practices meet federal requirements.
- Quality Release & Vendor Compliance: Manage the quality release of all incoming goods; inspect Certificates of Analysis (CoA) to verify raw materials meet technical specifications and shelf-life requirements.
- CAPA & Root Cause: Manage investigations for non-conforming materials and customer complaints, utilizing Root Cause Analysis (RCA) tools to implement effective corrective actions.
- Material Disposition: Oversee the disposition of non-conforming materials and drive cross-functional solutions to reduce production deviations and waste.
QMS Consultant / Operations Manager
SCD PROBIOTICS HOLDINGS
Kansas City, MO
08.2018 - Current
- QMS Consultant (Apr 2025 - Present): Audit Leadership: Utilize ISO 9001:2015 Lead Auditor training to spearhead all internal audit programs, identifying non-conformances and advising leadership on risk mitigation.
- Continuous Improvement: Manage Customer Complaint and CAPA logs; perform trend analysis to identify systemic issues and verify corrective action effectiveness.
- Quality Compliance: Enforce document control policies, ensuring revision control is strictly maintained for all hard copy and digital reference materials.
- Technical Tracking: Manage equipment calibration and ISO-compliant training matrices to ensure workforce competency.
- Operations Manager (Jan 2023 - Apr 2025): Operations Leadership: Directed QA/QC and Production departments, ensuring cGMP compliance while optimizing resource allocation for raw materials and packaging.
- Audit & Compliance: Played a lead role in FDA, Organic (QAI), and ISO audits; spearheaded the investigation/resolution of non-conformance reports and the CAPA lifecycle.
- Process Improvement: Utilized KPIs and Scorecards to enhance leadership accountability and streamlined production planning for optimal workflow efficiency.
- Team Development: Managed recruitment, performance evaluations, and payroll; delivered job training and safety protocols documented via the training matrix.
- Inventory Integrity: Drove inventory accuracy initiatives, providing regular metrics on precision and implementing corrective measures as needed.
- Strategic Metrics: Provided labor cost and overhead metrics to inform strategic resource allocation and leadership decision-making.
- QA/QC Supervisor (Feb 2020 - Dec 2022): Generated Certificates of Analysis (CoA) for all QC released products and managed lot numbers for sales orders.
- Wrote and updated SOPs, performed cycle counts, and managed equipment calibration records via tracking software.
- QC Technician (Aug 2018 - Jan 2020): Monitored fermentation processes and performed quality testing on raw materials and in-process samples.
Laboratory Research Technician
ANSERA ANALYTICS
Olathe, KS
10.2016 - 05.2018
- Patent & Innovation: Co-invented a proprietary sample transport prototype for select agents; conducted experiments to advance prototypes targeting infectious agents.
- Grant & Technical Writing: Authored portions of SBIR grant applications and Department of Defense monthly contract reports.
- Award: Received the 2018 Travel Award from the ASM Biothreats meeting in Baltimore, MD.
- Lab Management: Maintained BSL-2 stock cultures, performed DNA extraction, and LAMP analysis.
Analytical Chemist / Gene Expression Analyst
MONSANTO (via Today's Staffing)
St. Louis, MO
05.1998 - 07.2003
- Analytical Testing: Conducted characterization of Corn Ethanol Fermentation via HPLC and GC headspace analysis.
- Genetic Research: Detected transgenic genes via direct ELISA, PCR, and Protein Assays.
- Efficiency Gains: Developed an SOP for sample preparation that significantly increased extraction efficiency.
Education
Bachelor of Science - Biology
MISSOURI STATE UNIVERSITY
Springfield, MOSkills
- Continuous improvement
- ISO compliance
- Regulatory leadership
- CAPA management
- Audit readiness
- Strategic thinking
- Personnel training
Certification
- ISO 9001:2015 Lead Auditor Training, 360 Training Online Course
- Microbiology, Metropolitan Community College, Specialized training in Aseptic Technique, Gram Staining, and Pathogen ID (2015)
Timeline
Quality Assurance Manager
CERTIFIED SAFETY MANUFACTURING
04.2024 - Current
QMS Consultant / Operations Manager
SCD PROBIOTICS HOLDINGS
08.2018 - Current
Laboratory Research Technician
ANSERA ANALYTICS
10.2016 - 05.2018
Analytical Chemist / Gene Expression Analyst
MONSANTO (via Today's Staffing)
05.1998 - 07.2003
Bachelor of Science - Biology
MISSOURI STATE UNIVERSITY