Quality Control Assurance
Resume:
John Evans
Bethlehem, Pennsylvania 18020
(H) 610-***-****
**********@*****.***
Objective
Seeking a challenging position within the pharmaceutical/biotechnology or
chemical manufacturing industry to utilize my diversified experience in
Documentation, Compliance and Quality Control/Assurance.
Summary
A highly motivated, results focused, Technical Scientific Professional,
currently a Compliance Specialist at a major pharmaceutical company with
extensive experience in documentation control, writing SOP, audits, and
training. Previous supervisory experience in a Quality Control lab working
with bulk actives, excipients and finished products. Able to work on own
initiative and as part of a team with proven dedication to maintaining high
standards in both QC and QA environments.
Professional Experience
Merck Research Laboratories (formerly Schering-Plough Research Institute)
Kenilworth, New Jersey
Apr. 2006-Present: Compliance Specialist- GLP
. Perform Compliance reviews on DSM SOPs/LPs.
. Maintain files of all current and obsolete DSM SOPs/LPs
. Perform annual audits on Employee Training Manuals and SOP
Bookholder Manuals.
. Assist Archivists with archiving responsibilities and
changing Archive charts in K-15 and K-11.
. Maintain DSM Draft SOP spreadsheet and database.
. Author departmental SOPs/LPs and Protocols
. Train Scientists/Techs on SOPs/LPs
. Maintain SharePoint database for authors
. Maintain Access database for all draft departmental
SOPs/LPs.
. Administrator for Documentum database (Commander)
. Perform metrics on SOPs/LPs processed within the department
2001-2006: Compliance Specialist- GMP
. Perform compliance review of SOPs against Level II
Standards,
. Corporate Polices and GMP/GLPs
. Perform SPRISOP and Commander Administrator functions
. Coordinate distribution of SOPs to PharmSci
. Attending department meetings to support SOP compliance
issues
. Attended Lackman meetings to address SOP concerns
. Worked with SOP authors to develop and improve their SOPs
to meet regulatory and Schering Plough standards
. Attended meetings with SOP authors to discus technical,
compliance and formatting issues
2000 -2001: Compliance Coordination Auditor (through Joule
Scientific)
( Reviewed analytical data for FDA submission
( Wrote audit reports
( Reviewed company responses for NDA
submission
( Reviewed SOPs
The P.F. Laboratories, Inc. Totowa, New Jersey
1996-2000: Quality Control Supervisor
. Supervised nine analytical chemists dealing with bulk
actives, excipients and finished products.
. Assisted Quality Assurance with lab audits.
. Conducted cGMP and GLP training with Lab personnel.
. Maintained calibration system for lab equipment.
. Wrote SOP's and Quality standards for QC lab of app. 29
analysts. These SOPs are written for instruments, methods
and procedures to release products in the QC lab.
. Ordered lab equipment and supplies
Hoffmann-La Roche Nutley, New Jersey
1982-1995: Associate Scientist (Bioprocess Development)
. Performed extraction and purification of proteins.
. Performed Method Development research on proteins using LC,
HPLC, and Electrophoresis.
. Prepared and maintained batch records.
. Worked on scale up processes for Interleukin II protein.
. Worked in fermentation process for HAT protein.
. Supervised three co-workers in pegalated Interferon
production.
. Ordered lab equipment and supplies.
.
Engelhard Industries Newark, New Jersey
1980-1982: Technician
. Developed substrates used in the catalytic converters of
automobiles.
. Developed products, quality control analysis, and
distribution of samples and managing product inventory.
Education
. Temple University
Phil. Pa. (Jan 2002- Apr 2003) Certificate QA/RA
. William Paterson College,
Wayne, NJ (1979) B.A. Biology
HONORS AND AWARDS
. 2002 Schering-Plough Excellence Award
COMPUTER SKILLS
Microsoft Access /Microsoft Word
. Excel
. Blue Mountain Calibration Manager
. SPRISOP Administrator and SPRISOP Creator/Editor
. Commander Training (Documentum)
. SPRIDOX Training
. CSTS Crystal Reports
. SharePoint
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