Nicholas Schubert
Senior Management
Franklin,Tennessee
Summary
Quality-oriented professional with over 17 years of experience and a proven knowledge of regulatory compliance, patient safety, and laboratory management. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
2
2
years of post-secondary education
17
17
years of professional experience
Work History
Lab Manager/QA Consultant
Medical Arts Pharmacy
07.2011 - Current
- Developed business relationships with third parties, negotiated contracts and quality agreements, managed contract laboratory efforts.
- Conducted internal and external site audits of suppliers, contract laboratories and business partners.
- Authored protocols for process validation, environmental monitoring and testing of lab and personnel, analytical method transfer, instrument/equipment qualification, and computer software qualification.
- Reduced error rate to less than 0.5% through installation of thrice check system of verification.
- Utilize compounding devices in sterile and non-sterile compounding labs resulting in improved operational effectiveness and realized cost saving by $200K+ annually.
- Responsible for Out of Specification (OOS) and Out of Trend (OOT) investigations, Root Cause Analysis and Corrective and Preventative Actions (CAPA).
QA/Compliance Manager
The Health & Wellness Compounding Pharmacy
03.2014 - 07.2016
- Developed, implemented, and maintained continuous business process and quality improvement programs.
- Ensured constant state of inspection readiness through deliberate systemic monitoring of Quality Systems.
- Reduced costs by 30% and time to market by 40% through introduction of modern manufacturing techniques.
- Reduced annual chemical inventory by 300+% by improving operational effectiveness and adding barcoding technology.
- Provided quality and compliance training per 21 CFR 210 & 211 to eight (8) new and current technicians.
Director of Production
Pharmakon Pharmaceuticals
01.2011 - 02.2014
- Commanded superior leadership in support of ongoing cGMP production processes with expert oversight of sterile IV production facility.
- Delivered exemplary personnel administration and team leadership.
- Performed QA oversight per 21 CFR 210 & 211 to maintain compliance.
- Drove improved production efficiency with resultant cost savings of $900,000 on annualized basis and 200% increase in profitability by proposing automation of filling lines, eliminating need for 2-3 new hires.
- Increased quality and boosted production performance from accuracy and precision of 101% +/-12%with large STD and variability to 100.4% +/-2.3%, in perfect agreement with analytical lab’s measurement error of +/- 2%.
- Ensured per cGMP, 21 CFR 210 & 211 regulations by utilizing outstanding technical/ instructional skills to provide quality and compliance training to new and current technicians.
Pharmaceutical Microbiologist
Dynalabs LLC
09.2008 - 01.2011
- Devised/executed effective strategies and pharmaceutical assay techniques for validation of potency, endotoxin and sterility per FDA 21 CFR 211, GAMP, and ISO 17025 regulations.
- Expanded test capabilities by researching method development technologies.
- Performed QA oversight for data generated by laboratory tests and scrutinized paperwork for proper risk assessment prior to sample being released as pass/fail to customer.
- Recognized for consistent achievement and promoted to role of Pharmacy Consultant working closely with customers to improve quality and confidence in testing.
- Performed quality review of potency test results per 21 CFR 211.
- Elevated analytical/business performance by improving compounding processes and achieving potencies in top 5% of each respective market segment for customers’ pharmaceutical compounds.
- Increased staff capabilities by planning and implementing development and training program for chemistry lab and six (6) staff members.
Education
Bachelor of Science - Biological/Life Sciences
Excelsior College
01.2016 - 01.2017
Associate of Arts - General Education
St. Louis Community College
01.1998 - 01.1999
Skills
RDI RapidScan II, Sterile Pharmaceutical Productionundefined
Timeline
Bachelor of Science - Biological/Life Sciences
Excelsior College
01.2016 - 01.2017
QA/Compliance Manager
The Health & Wellness Compounding Pharmacy
03.2014 - 07.2016
Lab Manager/QA Consultant
Medical Arts Pharmacy
07.2011 - Current
Director of Production
Pharmakon Pharmaceuticals
01.2011 - 02.2014
Pharmaceutical Microbiologist
Dynalabs LLC
09.2008 - 01.2011
Associate of Arts - General Education
St. Louis Community College
01.1998 - 01.1999
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