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 CAPA's, deviations and OOS reports
• Able to orient and train new employees/scientists/technicians on strict compliance to departmental policies, Pharmacopeia methods, GMP's and GLP's
• Experience with Customer Service/complaints.
• Experience working with stability samples and creating stability reports.
• Used Excel spreadsheets to track documentation metrics.

Professional Experience

Confidential

• Responsible for auditing Packaging lines for Quality Assurance.
• Assisting in the authoring of SOPs, forms, and Protocols for Packaging Lines, Water Sampling procedures and Environmental Monitoring processes.
• 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.
• Monitored stability samples for packaging lines.
• Responsible for creating Excel spreadsheets for metrics on audits, packaging line clearances, and batch record turnarounds.

Confidential

• 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.

Confidential

• 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

Confidential

• 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

Confidential

• Administrator for Documentum database Commander
• Maintain Access database for all draft departmental SOPs/LPs.
• Maintained SharePoint internal database for authors
• Trained Scientists/Technicians on SOPs/LPs
• Maintained DSM Draft SOP spreadsheet and database.
• Authored departmental SOPs/LPs and Protocols
• Maintained the archival of controlled documents in adherence with department work instructions.
• Performed annual audits on Employee Training Manuals and SOP Bookholder Manuals.
• Maintained files of all current and obsolete DSM SOPs/LPs
• Performed Compliance reviews on DSM Drug Safety Metabolism SOPs/LPs.
• Performed metrics on SOPs/LPs processed within the department and tracked the metrics in an Access database
• Performed audits on lab documentation

Confidential

• 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

Confidential

• Reviewed analytical data for FDA CMC submissions
• Wrote audit reports
• Reviewed company responses for NDA submissions
• Reviewed SOPs

Confidential

• 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.
• Responsible for reviewing Pharmacopeia methods and updating any changes to lab procedures when changes are directed as per Supplements.

Confidential

• 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.

Confidential

• Developed substrates used in the catalytic converters of automobiles.
• Developed products, quality control analysis, and distribution of samples and managing product inventory.