JANIECE HOLMES
Frederick,MD
Summary
Determined Quality Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
16
16
years of professional experience
Work History
QC SPECIALIST
EMERGENT BIOSOLUITIONS
09.2020 - 07.2023
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Recorded and organized test data for report generation and analysis.
- Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
- Adhered to safety and clean area procedures to comply with agency and regulatory mandates.
- Identified and resolved variances to bring products in line with requirements.
- Inspected Raw Materials and Consumables and compared against standards to meet regulatory requirements.
- Conducted data review and followed standard practices to find solutions.
- Provided training to over 25 onboarding team members in 2021-2022.
- Liaised between quality control and other departments and contractors, providing project updates and consultation.
- Conducted analyses of raw material release, components and products and reduced TAT to ~30 days from >60 days on average.
QA Specialist I- QA Systems
EMERGENT
Rockville, MD
07.2022 - Current
- Educates employees on specific QA standards and confirmed maintenance of standards.
- Monitors product standards and quality-control programs.
- Provides regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Inspects, verifies and documents quantifiable characteristics of finished goods by comparing against customer specifications and company quality standards.
- Collaborates with management to provide training on improved processes and assisted with creation and maintenance of quality notifications generated by suppliers.
- Fixed identified issues to increase productivity and boost workflows for backlog of supplier notifications, supplier corrective actions by reducing overdue records from over 200 to zero overdue actions.
- Collects and analyzes activity data and initiates, develops and recommends improvements to systems, processes and procedures to increase productivity and reduce cost.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Fixed identified issues to increase productivity and boost workflows.
- Develops monthly, end-of-quarter and other statistical reports for leadership team and quality improvement programs.
- Implemented use of Smartsheet and Power BI tools to illustrate project features and requirements for Material Qualification and Supplier Quality
- QA SME/Site Rep for onboarding over 30 materials needed for new manufacturing line.
- Participated in team projects, demonstrating ability to work collaboratively and effectively
- Acted as leader of cross functional team of 8, delegating tasks and providing feedback
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution
QC ANALYST III
EMERGENT BIOSOLUTIONS
07.2019 - 09.2020
- Performed environmental monitoring and utility testing of facility, and during fill operations
- Assisted Manager with feasibility assessment of client and in-house projects
- Performed microbiological/analytical work per method transfer/validation programs
- Performed various microbiological/analytical testing procedures per Quality Control batch records and stability protocols
- Participated in investigations of OOS results
- Wrote, Reviewed and Revised SOP's and methods as necessary
- Qualified Trainer and Subject Matter Expert in Aseptic Technique, Basic Contamination Control and Review training over 25 employees.
- Reviewed, analyzed, interpreted, and reported routine and batch related data
- Worked closely with management to ensure all timelines were met for purchasing
- Worked closely with Project Managers and QA to ensure timely review and approval of protocols/ reports
- Supported and helped to encourage department compliance and productivity goal
- Authored and Revised Change Controls, and Raw Material Specifications
- Assisted with purchase ordering for lab consumables and supplies
- Improved reliability of supply chain software, systems, database and order processing
- Developed streamlined task system to provide more effective workflows for both peers and management staff
- Completed quality assurance reviews to assess accuracy of data and validate results.
- Developed strong organizational and communication skills through coursework and volunteer activities
- Strengthened communication skills through regular interactions with others
QC ANALYST III
Lonza
10.2018 - 07.2019
- Supported Aseptic Process Validations (APSs) by performing environmental monitoring (EM), screening and counting fill-samples, and completing APS related documentation
- Executed Environmental Monitoring in ISO5/7/8 clean rooms adhering to all applicable SOPs for clean rooms, quality control and quality assurance
- Participated in the development GMP reports such as, trend reports, SOPs, and documents to support equipment operation
- Held Responsible for the proper maintenance and use of equipment in strict accordance with cGMPs, SOPs and safety policies
- Assisted in trending EM Data and investigates all OOS specifications
- Identified and assisted in investigating and implementing appropriate CAPAs
- Performed Microbial Enumeration and assisted with Microbial Identification
- Performed sampling of Compressed Air/Utility Systems
- Qualified/ Trained varying personnel for Sterile Gowning
- Initiated and assisted with completion of EENs (Environmental Excursion Notices) and deviation investigations
- Helped with data acquisition and review through MODA (Mobile Data Acquisition) software
- Assisted with lab maintenance
QC ANALYST III
RELEASE TESTING
03.2016 - 10.2018
- Supported Aseptic Process Validations (APSs) by performing environmental monitoring (EM), screening and counting fill-samples, and completing APS related documentation
- Supported cleaning validations by performing environmental monitoring (EM) and completing related documentation
- Performed Environmental Monitoring for routine procedures
- Performed plate enumeration, and microbial notifications
- Assists with lab maintenance: stocking,
- Performed assays such as Growth Promotion Qualifications, Sterility by Membrane Filtration, Rapid Detection of Mycoplasma using MycoAlert system, Bio Burden using Milliflex pump systems, Trypsinization/Seeding of Vero Cells, and Rapid Gross Sterility using the HB&L AliFax System
- Helped to develop and assisted with Installation/Qualification of new equipment
- Performed/ reviewed data entries as assigned through the SAP Portal
- Prepared trend analysis reports, method validation protocols and final reports
- Wrote and revised SOPs/conducted deviation investigations
- Performed process validations/performance qualification (PQ) training.
QUALITY CONTROL ANALYST
01.2008 - 01.2015
- Performed routine assays.
- Received, distributed, tracked, and coordinated cGMP samples for testing
- Managed raw material sampling, inspection, release and rejection
- Kept accurate testing records and assured that laboratory equipment was calibrated, standardized, and monitored as appropriate
- Wrote, Reviewed, and edited SOP(s)
- Responsible for training of 3 new analyst for Environmental Monitoring
- Method Validation Protocol execution for sterility using Isolator
- Revamped Environmental Monitoring Program for newest facility.
- Inspected items and compared against standards to meet regulatory requirements
Education
CI -
2021
Lead/Practitioner: Yellow Belt Equivalent, Emergent BioSolutions LLC
BACHELOR OF SCIENCE - BIOLOGY
2009
Skills
- Establishing and Enforcing Policy
- Forecasting & Planning
- Operational Excellence Improvement
- Productivity Benchmarks
- Sound Quality Management Techniques
- Correction Action Planning
- Vendor Relations
- Problem-Solving Skills
- Project Management
- Team Leadership
- Sound Decision-Making Abilities
- Quality Improvement/Quality Assurance
- Analytical Thinking
Timeline
QA Specialist I- QA Systems - EMERGENT
07.2022 - Current
QC SPECIALIST - EMERGENT BIOSOLUITIONS
09.2020 - 07.2023
QC ANALYST III - EMERGENT BIOSOLUTIONS
07.2019 - 09.2020
QC ANALYST III - Lonza
10.2018 - 07.2019
QC ANALYST III - RELEASE TESTING
03.2016 - 10.2018
QUALITY CONTROL ANALYST -
01.2008 - 01.2015
Operational Excellence - CI,
COPPIN STATE UNIVERSITY - BACHELOR OF SCIENCE, BIOLOGY