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.