Quality Control Assurance

John Evans

Email: abqgsb@r.postjobfree.com

Address: **** ******* **

City: Bethlehem

State: PA

Zip: 18020

Country: USA

Phone: 610-***-****

Skill Level: Experienced

Salary Range: $75,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

John Evans

3080 Margate Road

Bethlehem, Pennsylvania 18020

(H) 610-***-****

Email: abqgsb@r.postjobfree.com

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 and Customer Support.

Summary

A highly motivated, results focused, Technical Scientific Professional. A Compliance Specialist with extensive experience in documentation control, writing SOP, audits, and training. Additional supervisory experience in a Quality Control lab working with bulk actives, excipients and finished products. Demonstrated ability to work both independently and as part of a team with proven dedication to maintaining high standards in both QC and QA environments.

Skills

* Extensive experience with technical writing including SOP's, and controlled documents, and records management

* Creation/maintenance of Archival data base(s)

* Maintenance of various quality systems databases such as change control, deviation, computer system change control

* System Administrator for Documentum, Sharepoint, and Access databases used in Drug Safety Department at Merck.

* Created Access database system to track documents, deviations, metrics, and terminology that was used in Drug Safety department at Merck

* Knowledge of GMP/GLP and CFR regulations

* Performed CAPA investigations on OOS intermediate and finished products

* Worked with liquid production (Betadine) solution area to ensure quality intermediate and finished product

* Track metrics of deviations and OOS reports

* Able to orient and train new employees/scientists/technicians on strict compliance to departmental policies, GMP's and GLP's

* Experience with Customer Service/complaints.

Professional Experience

Daiichi Sankyo Inc. (Bethlehem, Pa)

Dec 2011 - Present (QA Investigator)

* Responsible for auditing Packaging lines for Quality Assurance.

* Assisting in the authoring of SOPs and Protocols.

* Responsible for performing audits on incoming Bulk and packaging components in Warehouse environment.

* Responsible for initiating Deviation reports, Quarantine reports and CAPAs.

* Responsible for performing Micro, TOC, Product and detergent residue swabbing for validation testing and creating reports for quarterly plant environmental monitoring program.

* Responsible for performing viable, non-viable and contact plate environmental monitoring on compressed air and room air for a packaging facility.

Sandoz (Mechanicsburg, PA)

Nov 2011 - Dec 2011 (QA Supervisor through Excel/Sandoz)

* Responsible for reviewing and approving inbound and outbound shipment documentation

* Reviewing datalogger information to ensure that shipments were shipped at the proper temperatures

* Reviewing Sandoz and Exel Shipping SOPs for compliance to FDA regulations.

* Performing Warehouse inventory to ensure SAP database is correct.

Sharp Corporation (Allentown, Pa)

June 2011 - August 2011 (QA Supervisor through Joule Clinical & Scientific)

* Responsible for the supervision of nine inspectors in Packaging facility.

* Initiated deviation reports when packaging inspections detected an OOS result.

* Responsible for training inspectors on new SOPs and deviation reports.

* Responsible for the inventory of Controlled drugs in and out of vault.

* Responsible for the scheduling of inspectors on second shift and weekends

Sanofi-Aventis US Quality and Compliance, Bridgewater, NJ

Oct. 2010- April 2011: QA Specialist (through Patni)

* Analyzes customer complaints, both product and technical, in the Sanofi- Siebel call center.

* Works on the Siebel database entering all complaints

* Determine qualification of complaint: potential adverse effect vs. product technical complaint

* Interact directly with customers, patients, pharmacies

Merck Research Laboratories (formerly Schering-Plough Research Institute)

Kenilworth, New Jersey

Apr. 2006-Sept. 2010: Compliance Specialist- GLP

* Performed Compliance reviews on DSM (Drug Safety & Metabolism) SOPs/LPs.

* Maintained files of all current and obsolete DSM SOPs/LPs

* Performed annual audits on Employee Training Manuals and SOP Bookholder Manuals.

* Maintained the archival of controlled documents in adherence with department work instructions.

* Authored departmental SOPs/LPs and Protocols

* Maintained DSM Draft SOP spreadsheet and database.

* Trained Scientists/Technicians on SOPs/LPs

* Maintained SharePoint (internal) database for authors

* Maintain Access database for all draft departmental SOPs/LPs.

* Administrator for Documentum database (Commander)

* Performed metrics on SOPs/LPs processed within the department and tracked the metrics in an Access database

* Performed audits on lab documentation

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 cGLP training with Lab personnel.

* Maintained calibration system (Blue Mountain) 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

* Maintained raw materials inventory for lab

* Worked with the manufacturing facility to ensure quality product testing of intermediate and finished product.

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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