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Skills

  • Lean manufacturing processes
  • Business operations
  • Team building
  • Root cause analysis
  • Continuous Improvement Initiatives
  • MS Office
  • Regulatory compliance
  • Results interpretation
  • SAP systems
  • Data integrity in pharmaceutical testing

Work Experiences

  • Collaborated with quality assurance.
  • Contributed to regulatory approval in 2024.
  • Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records, and work instructions.
  • Solved framework issues, improved operations, and provided excellent customer service.
  • Repaired, calibrated, and safely operated laboratory equipment to reduce costly instrument downtime.
  • Planned and carried out analytical tests in accordance with established guidelines and specifications.
  • Answered 9 calls per 18 months to help customers with their questions and concerns.
  • Assisted with the collection, identification, and packaging of hazardous and non-hazardous waste products to comply with Resource Conservation and Recovery Act regulations.
  • Contributed to revised methodology.
  • Achieved 11% reduction in stockout events.

Summaries

  • Over 6+ years in Miscellaneous, I've become well-organized and detail-oriented, with strong project management and planning skills.
  • Within Miscellaneous, senior Pharmaceutical Analyst and outstanding performer in cross-functional collaboration and performance reporting.
  • Contributed to decreased downtime.
  • Strengths in process improvement and cross-functional collaboration backed up by Miscellaneous training.
  • Data-focused analyst specializing in advanced statistical tools.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Pharmaceutical Analyst is a multi-talented Pharmaceutical Analyst who is consistently rewarded for planning and operational improvements.
  • A versatile chemist who can work with a wide range of chemicals, compounds, and materials.
  • Assured data integrity across diverse locations.
  • Analytical professional skilled in reducing sample turnaround time by 9% while improving sample identification procedures and overall laboratory efficiency.

Accomplishments

  • Identified and resolved raw material quality inconsistencies, leading to a reduction in stockouts by 46%.
  • Documented and resolved procedure which led to standard.
  • Standardized method transfer protocols between internal and external labs, reducing overall transfer time by 7 weeks and ensuring seamless execution.
  • Optimized raw material release processes, resulting in a 3% reduction in production delays, helping maintain consistent manufacturing schedules.
  • Collaborated closely with product development teams to establish stability protocols that ensured the long-term chemical integrity of pharmaceutical products.
  • Developed and validated stability-indicating assays, improving shelf-life projections by an estimated 13 months months, supporting long-term product viability.
  • Improved accuracy of degradation product identification by 59% by utilizing advanced analytical techniques, leading to better product stability insights.
  • Collaborated with team of 16 in the development of category.
  • Drove the vendor qualification process for new analytical instruments, ensuring compliance with all regulatory standards and improving analytical throughput.
  • Contributed to product lifecycle management by improving analytical techniques for degradation monitoring, enabling better predictions for product discontinuation timing.

Affiliations

  • Biomedical Research Alliance of New York (BRANY)
  • Lions Club
  • Bioanalytical Consortium (BAC)
  • American Society of Safety Professionals
  • International Society for Pharmaceutical Engineering (ISPE)
  • National Organization of Rare Disorders (NORD)
  • American Marketing Association
  • Infectious Diseases Society of America (IDSA)
  • Society of Quality Assurance (SQA)
  • Toastmasters

Certifications

  • Root Cause Analysis in Pharmaceuticals Certification - initiative
  • CompTIA A+ Technician
  • GxP (Good Practices) Certification - Vantage
  • Certified Public Accountant
  • Cisco Certified Network Associate (CCNA)
  • Certified Quality Auditor (CQA) Northwind
  • Master Certificate in Biopharmaceutical Operations - metric
  • Certified Stability Professional (CSP) - method
  • ISO/IEC 17025 Certification - method
  • Certified Lean Six Sigma Green Belt (CLSSGB) - Northwind

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