Nicholas

Schubert

Senior Management

Professional 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.

Work History

US FDA Regulatory Agent

bene pharmaChem

• Assisting FDA in communications with the foreign establishment.

• Responding to questions concerning the foreign

establishment’s chemicals that are imported or

offered for import into the United States.

• Assisting FDA in scheduling inspections of the

foreign establishment.

• If FDA unable to contact foreign establishment

expeditiously or directly, FDA may provide

information or documents to myself, and such an

action shall be considered to be equivalent to

providing the same information or documents to

the foreign establishment.

Lab Manager/QA Consultant

Medical Arts Pharmacy

• Developed business relationships with third parties, Contact

Address

Saint Charles, MO 63301

Phone

314-***-****

E-mail

ad2mze@r.postjobfree.com

LinkedIn

Schubert LinkedIn

WWW

Online Resume

Skills

RDI RapidScan II, Sterile

Pharmaceutical

Production

CGMP, GLP, GCP, USP,

FDA, 21 CFR 210 & 211,

GAMP, ISO 17025

PCR, HPLC, UV-VIS, LPA

Instrumentation

Biological, Chemical, Cell

Culture, and Genetic

Techniques

Strategic Business Planning

Contract Development /

2011-07 –

Current*

2022-01 –

Current*

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

• 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

Negotiations

Budget Administration /

Management

Process Redesign /

Change Management

Validation

First Aid/CPR

2014-03 -

2016-07

2011-01 -

2014-02

Pharmakon Pharmaceuticals

• 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

• 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.

2008-09 -

2011-01

• 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.

*Current work with bene pharmaChem & Medical

Arts has been on a consultant basis maintaining

P&P’s and assisting with staffing PRN when not

working for them on a FT basis

Education

Bachelor of Science: Biological/Life

Sciences

Excelsior College - Albany, NY

Graduated Cum Laude

Associate of Arts: General Education

St. Louis Community College - St. Louis, MO

Member of Phi Theta Kappa

.

2016-01 -

2017-01

1998-01 -

1999-01

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