Quality Assurance Control

SCOTT M. KRUPA

*** **** ****** ****, *********, New Jersey 08867-4108

telephone 908-***-**** fax 908-***-**** cell 908-***-**** email ***********@*******.***

PERSONAL STATEMENT

I am a Quality Assurance professional who is specialized in regulated industries biotech manufacturing, consumer products and

packaging.

EMPLOYMENT HISTORY

Manager of Quality Assurance/Quality Control

Tekni-Plex, Somerville, NJ (packaging for the healthcare, consumer and food industries)

11/2007-Present

• Responsible for responding to customer complaints and the execution of corrective and preventive actions.

• Maintain the Drug Master File and provides Letters of Authorization.

• Responsible for maintaining ISO and cGMP compliance.

• Final review of production records.

• Manage customer specification files.

• Review, approval and generation of Standard Operating Procedures and Work Instructions.

• Conduct internal and external audits.

• Evaluate and qualify new suppliers.

• Manage Quality Assurance Associates.

Quality Assurance Supervisor

Consumer Product Testing, Fairfield, NJ

3/2003-11/2007

• Provide supervision and direction to Quality Assurance Associates, including hiring, assigning projects, monitoring

attendance and participating in performance evaluations.

• Responsible for conducting internal departmental audits.

• Oversee quality audits and final review of regulated clinical studies.

• Responsible for auditing studies performed according to cGMP, cGLP and cGCP principles.

• Experienced in FDA audits.

• Insure that Quality Assurance review of data and reports are conducted in a timely basis.

• Maintain the Master Schedule for cGLP studies.

• Creation and revision of departmental SOPs.

• Manage document control areas to insure the security of all documents, validation studies, calibration and preventative

maintenance records.

Validation Engineer

Cooper Surgical, Inc., Cranford, NJ (manufacturer of disposable medical devices)

11/2000-2/2003

• Conducted process validation studies on Class I and Class II medical devices.

• Responsible for writing validation master plans, process validation study protocols and equipment qualification protocols.

• Creation and revision of departmental SOPs.

• Performed equipment qualification studies.

• Accountable for writing final reports for equipment qualifications and process validation studies.

• Conducted equipment calibrations.

• Processed change requests.

• Applied statistical concepts used for process capability analysis and sample size determination.

• Responsible for writing Process Failure Mode and Criticality Analysis.

• Performed Failure Investigations.

• Experienced in FDA audits.

• Supervised Production Technicians conducting process validation studies.

Processing Technician

Musculoskeletal Transplant Foundation, Edison, NJ (tissue bank that prepares human tissue for transplant)

5/1998-11/2000

• Produced, prepared, measured and packaged human tissue allografts for transplantation.

• Machined bone tissue using CNC (computer numerically controlled) milling machines.

• Aseptically processed grafts in a class 10 clean room.

• Performed final product inspection, tissue culturing, packaging and labeling.

• Worked in a strong team environment, including on-call status for weekends.

Scott Krupa Page 2 5/6/09

Senior Manufacturing Operations Trainer

Cordis, Warren, NJ (manufacturer of stents and the stent delivery system)

9/1995-5/1998

• Responsible for the training and supervision of technicians in the manufacture of Stent Delivery System Catheter.

• Monitored progress of trainees and wrote weekly status reports.

• Conducted knowledge and skill checks on trainees in the balloon catheter assembly department.

• Evaluated trainees accordingly upon completion of training.

EDUCATION

Rutgers University, Cook College, New Brunswick, New Jersey. Attended 1979-1981, majored in Microbiology. Relevant courses:

Scientific and Technical Writing, General Chemistry, Introduction to Experimentation, Organic Chemistry, Microbiology, Biology I

& II, Animal Science, Pre-calculus I & II, Calculus I and Agriculture Economics.

CERTIFICATIONS & WORKSHOPS

2000-2003 Member of the American Association of Tissue Banks - Tissue Bank Specialist Certification #900075.

•

Essential Process Validation: Elements and Applications, June 2001 Medical Design & Manufacturing Conference and

•

Workshop.

How to Supervise People, Rockhurst University Continuing Education Center, May 2003.

•

FIFRA and GLP Overview (EPA) presented by Sally Hayes of SRC Scientific & Regulatory Consultants, July 2006.

•

Fundamentals of Supplier DMFs presented by Montesino, November 2008.

•

SKILLS

Regulatory Agency audit experience

•

Skilled in data auditing and final report review

•

Generating SOPs and Work instructions

•

Thorough understanding of validation principles

•

Skilled with CNC machinery

•

Statistical analysis

•

Detail oriented and strong organizational abilities

•

Computer literate, Microsoft Office software

•

REFERENCES

Available upon request.

Contact this candidate