Rachel Spanka Senior Specialist, Quality
Staunton,VA
Summary
Knowledgeable Senior Quality Specialist with deep understanding of GMP and quality systems. Experienced with deviation management and change control. Strong focus on team collaboration and adaptability to dynamic environments. Seeks every opportunity to improve operations and team performance.
Overview
8
8
years of professional experience
Work History
Senior Specialist, Quality Analyst
Merck & Co.
08.2022 - Current
- Supervise laboratory technicians conducting analytical, chemical, and microbiological testing on in-process samples
- Routinely conducts second person review of in-process and intermediate sample testing using instrumental methods such as IR, GC, HPLC, UPLC, KF
- Assists with laboratory GMP activities by performing PM/PV and instrument troubleshooting
- Interacts with and fully understands LIMS, SAP, Empower, LabX and various data acquisition/management softwares for stand alone laboratory systems
- Provides project analysis including analytical method validations, new laboratory instrument installations and qualifications, instrument troubleshooting, and project management
- Provides 12 hour shift coverage for vacation/illness relief which includes working evenings, overnights, and weekends
- Routinely participates in deviation management and authors quality notifications
- Routinely participates in change control management and authors updates to test methods and adjuncts
- Authors and executes analytical method validations
- Writes, reviews, and approves standard operating procedures
- Advocates new technology installations and serves as the subject matter expert
- Trains other analysts on laboratory instrumentation and techniques.
- Drove change through quality-oriented strategies to help operations accomplish ambitious short- and long-term goals.
- Supported department leadership in implementing new policies, procedures and controls.
- Collaborated with cross-departmental teams in developing cohesive strategies aimed at achieving long-term organizational goals.
- Fostered culture of continuous improvement, leading by example and encouraging innovation at all levels.
Specialist, Quality Analyst
Merck & Co.
04.2021 - 08.2022
- Completed second person review of sample testing, PM/PV, paper documentation and electronic data records
- Able to understand and interact with data acquisition/management software systems such as SAP, LIMS, Empower, and LabX
- Full understanding of laboratory GMP
- Experience with deviation management, CAPAs, and change control
- Experience with writing and reviewing standard operating procedures
- Experience with instrument qualification and decommissioning.
Project and Change Management Coordinator
Kerry Harrisonburg
10.2019 - 04.2021
- Worked independently with minimal supervision
- Worked across multiple projects at a time
- Self-guided and creative in seeking solutions
- Strong desire to succeed and help others
- Able to examine issues from various perspectives
- Collaborate with partners and present findings and progress.
Plant Operations Assistant/Documentation Specialist
Kerry Harrisonburg
10.2019 - 04.2021
- Conducted quality control checks and implemented systems for effective data management
- Evaluated and implement methods, procedures, SOPs, and techniques based on established objectives
- Experience with data collection and management for KPIs (Key Performance Indicators) on multiple levels
- Experience with continuous improvement management and corrective and preventative action.
Quality Control Technician
Kerry Harrisonburg
06.2019 - 10.2019
- Maintained daily operations of the laboratory
- Accurately performed analytical and chemical testing and maintained documentation
- Entered analytical data
- Assisted in monitoring raw material and finished products specifications
- Assisted in reviewing pre-shipment approval documentations
- Completed all paperwork accurately and in a timely manner
- Performed calibration checks and tests on measuring equipment
- Applied Good Manufacturing Practice in manufacturing and laboratory instrumentation.
Home Health Aide
Care-Free Home Health and Companions
07.2017 - 08.2019
- Worked with individuals with severe mental disabilities
- Analyzed and implemented plan of care for each patient
- Assisted patients by providing personal services, such as hygiene, bathing, dressing and grooming.
Lab Assistant
Eastern Mennonite University
09.2016 - 12.2016
- Assisted Chemical Hygiene Officer with routine safety equipment testing, chemical inventory and waste disposal
- Restocked and organized supplies
- Cleaned, moved and organized glassware and lab equipment across Chemistry and Biology departments.
Education
Bachelor of Science in Biochemistry -
Eastern Mennonite University
05.2019
Skills
- Documentation Management
- Root Cause Analysis
- Proficient in LIMS, SAP, Empower, LabX and Various Stand Alone Systems
- Problem-Solving
- Time Management
- Analytical Thinking
- Team building
- Technical communication
- Quality Assurance
Lab Qualities
- Keeping a clean and safe work environment
- Effective decision making skills
- Knowledge of relevant GMPs and regulations
- Knowledge of quality systems, deviation management, and change control
Equipment, Skills, Experience
- Fourier-Transform Infrared Spectroscopy
- Nuclear Magnetic Resonance Spectroscopy
- Gas Chromatography
- Ultra-Performance Liquid Chromatography
- High-Performance Liquid Chromatography
- Gel-electrophoresis
- Aseptic Technique
- Volumetric KF
- Titrations (manual and auto)
- Calibration of Instruments
- Micro-pipetting
- Use of Ventilated Balance Exposures
- Spectrophotometry
- Conductivity
- Total Organic Carbon Analyzer
- Preventative Maintenance and Performance Verification of Laboratory Instruments
- Turbidimetric Limulus Amebocyte Lysate Analysis
- Heterotrophic Plate Count
- Product Bioburden
- Growth Promotion
- Nitrates
- Biosafety Cabinets
- Environmental Monitoring
- Environmental Excursions
- Water Filtration
Laboratory Experience
Completed one year of independent lab research at Eastern Mennonite University, 4 years of laboratory chemical testing experience at Eastern Mennonite University, and 4 years of quality and laboratory experience in the pharmaceutical industry.
Timeline
Senior Specialist, Quality Analyst
Merck & Co.
08.2022 - Current
Specialist, Quality Analyst
Merck & Co.
04.2021 - 08.2022
Project and Change Management Coordinator
Kerry Harrisonburg
10.2019 - 04.2021
Plant Operations Assistant/Documentation Specialist
Kerry Harrisonburg
10.2019 - 04.2021
Quality Control Technician
Kerry Harrisonburg
06.2019 - 10.2019
Home Health Aide
Care-Free Home Health and Companions
07.2017 - 08.2019
Lab Assistant
Eastern Mennonite University
09.2016 - 12.2016
Bachelor of Science in Biochemistry -
Eastern Mennonite University
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