Hi, I’m
NICHOLAS SCHUBERT
St. Louis,MO
Overview
14
years of professional experience
Work History
bene-Arzneimittel GmbHGeretsried, BY
US FDA Regulatory Agent
02.2022 - Current
Job overview
- Company Overview: a German pharmaceutical company that produces and exports high-quality chemicals to the United States
- Provided timely and accurate responses to inquiries about foreign establishment chemicals, facilitating efficient import processes and fostering positive relationships with stakeholders
- Assisting FDA in scheduling inspections of the foreign establishment
- Ensured seamless communication between FDA and foreign establishments, leading to a 25% reduction in regulatory discrepancies and improved overall compliance, positively impacting business operations
- A German pharmaceutical company that produces and exports high-quality chemicals to the United States
Medical Arts Clayton PharmacyClayton, MO
Lab Manager / QA Consultant
07.2011 - Current
Job overview
- Improved supplier and laboratory compliance by 20% through conducting thorough internal and external audits, negotiating better terms on chemical procurement, ensuring high quality standards and regulatory compliance
- Drove error rate below 0.5% by instituting a thorough triple check system, leading to enhanced precision and trust in the quality of work
- Improved operational effectiveness and achieved annual cost savings of over $500K by implementing compounding devices in sterile and non-sterile labs and pharmaceutical chemical purchase agreements renegotiated
Health & Wellness Compounding PharmacyNashville, TN
QA Compliance Manager
03.2014 - 07.2016
Job overview
- Streamlined operations and reduced errors by 25% through the implementation and maintenance of continuous quality improvement programs, resulting in improved compliance and regulatory adherence
- Enhanced productivity by 30% and decreased time to market by 40% by integrating advanced manufacturing methods, leading to increased profitability and market share
- Enhanced operational efficiency and introduced barcoding technology, leading to a 300% decrease in annual chemical inventory, optimizing resource utilization and increasing cost savings
- Educated 8 technicians on 21 CFR 210 & 211, resulting in increased awareness and adherence to quality and compliance standards
Summary
Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Education
Excelsior CollegeAlbany, NY
Bachelor of Science from Biological Sciences
Skills
- QA procedure development
- Quality controls
- Procedure monitoring
- Data management
- Laboratory work supervision
- Protocol optimization
- Research coordination
- Standard operating procedures
- Equipment maintenance
- Chemical handling
- Employee supervision
- Environmental monitoring
- Data interpretation
- Experimental design
Availability
See my work availability
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Available
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friday
saturday
sunday
morning
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evening
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Work Preference
Work Type
Full TimeContract WorkPart TimeWork Location
HybridRemoteOn-SiteImportant To Me
Career advancementWork-life balanceFlexible work hoursLanguages
English
Native or Bilingual
Interests
Cancer Research
Alzheimer's Research
Timeline
US FDA Regulatory Agent
bene-Arzneimittel GmbH
02.2022 - Current
QA Compliance Manager
Health & Wellness Compounding Pharmacy
03.2014 - 07.2016
Lab Manager / QA Consultant
Medical Arts Clayton Pharmacy
07.2011 - Current
Excelsior College
Bachelor of Science from Biological Sciences
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