SUMMARY:

• Strong knowledge of data structure
• Strong knowledge of Integration and relational database design
• Excellent documentation skills
• Extensive knowledge of bio - pharmaceutical manufacturing and regulatory products
• Extensive experience working with database objects (LabWare LIMSv5,6 and 7, ThermoFisher LIMS-Sample Manager, STARLiMS LIMSv10.5 (ELN and Inventory), SMARTLAB, EMPOWER, Microsoft Access and Excel Formula)
• Ability to set priorities, coordinate multiple tasks, and work well under pressure
• Experienced in Personal Protective Equipment (PPE) and handling hazardous materials.
• Project management and good team building skills
• Strong communication and organizational skills
• Proficient with programming languages such as Java, Python and Perl
• Experienced working with integration of multiple data sources from databases/data warehouses
• Good understanding of quality measurement and quality improvement methods
• Extensive knowledge of bio-pharmaceutical manufacturing computerized systems like DeltaV.
• Ability to work with diverse audiences
• Biopharmaceutical research
• Meticulous record keeping of Lab Reports
• Proper Gowning in Confidential Areas
• Experienced with programming queries, macros, and statistical procedures
• Experienced mid-level programmer
• Proficient with Database Querying languages such SQL
• Strong Knowledge of GLP, GMP, Confidential Requirements

PROFESSIONAL EXPERIENCE:

Confidential

System Lab Engineer, Devens, MA

Responsibilities:

• Creating and maintaining QC Micro LIMS templating and static data builds for EM and water sample sites, limits, specifications, test schedules and sampling plans.
• Providing support, troubleshooting the analytical and microbiology laboratories for data management systems
• Sustaining data management systems as required to support routine testing activities, method transfers and validations as well as change control activities around these methods or systems.
• Communicating issues, technical failures, and activity status updates to direct supervisor.
• Providing direct support to laboratory personnel to troubleshoot Tier 1 issues.
• Providing supports for the implementation of change controls associated with LIMS, SmartLab and Empower in response to audit observations or investigations.
• Participating on a variety of teams in support of business process improvement projects.
• Supporting the development and qualification of kinetic chromogenic endotoxin testing methods for raw material, in-process, buffer and BDS samples to establish a routine Endotoxin testing program.

Confidential

Quality control specialist, Andover, MA

Responsibilities:

• Created/modified objects in the LabWare LIMS database
• Designed/configured master data objects in support of Pharmaceutical procedures and conformance standards
• Developed/executed test scripts for master data objects in a Confidential manner
• Worked with the Business Owners to develop user requirements for new or modified master data objects
• Worked with the Business Owners to demonstrate new object functionality
• Worked as a Systems Analyst supporting the LabWare LIMS system

Confidential

Quality assurance specialist, Somersworth, NH

Responsibilities:

• Supported the release of measurement equipment, gauges, fixtures, and tools.
• Created/maintained the test plans and documents.
• Reviewed the of accompanied project documents.
• Coordinated the creation of series control plan.
• Reviewed drawings for compliance with internal policies and all quality relevant subjects/characteristics (eg. Special characteristics, tolerances, during serial testing).
• Documented deviations or conditions in coordination with Application Engineering.

Confidential

Manufacturing Associate, Portsmouth, NH

Responsibilities:

• Performed troubleshooting and resolving process related issues in order to avoid deviation in manufacturing processes
• I nitiated and documented minor deviations, change-over and hand-over processes in GMP.
• A ccurate execution of critical and routine production operations according to the SOPs and Batch records e ntered data in the Laboratory Information Management System (QLIMS) and submission of samples to QC for further testing e nsured accuracy in recording data into log books
• Reviewed log books for accuracy according to GMP requirements to ensure Zero-Error in the GMP records
• Conducted sample preparation like hypochloric solutions used in purification and fermentation departments and submitted samples of the prepared buffer solution to the QC for further purity testing.
• Proposed document revisions when necessary by using the required batch records recommendations or based on the work requirements.

Confidential

Repository Technician, Rockville, MD

Responsibilities:

• Procured inventories, and withdrew biological specimens of human origin at temperatures ranging from -190°C to ambient temperature
• Uncrated, analyzed, and deposited incoming samples into the appropriate storage locations
• Prepared and stored biological samples for shipment and ensured that samples were placed within the proper storage freezers for preservation
• Consolidation of inventory: prepared samples and documentation for pickups, courier deliveries, and shipments.
• Ensured all job related paperwork was accurately entered into operating systems daily
• Worked with project managers to arrange transportation schedules with approved carriers and accurately reported to carrier billing arrangements, as well as documents on air bill.
• Performed data entry of samples into a computerized database for sample tracking and management
• Prepared paperwork for maintaining inventory of ongoing research projects

Confidential

Manufacturing associate, Rockville, MD

Responsibilities:

• Conducted chemical research and gained expertise with a wide range of biopharmaceutical tools, equipment, and research techniques
• Operated fermenter tanks according to the SOPs or the product batch records
• Maintained aseptic techniques in all the process runs
• Performed Steaming in Place (SIP), Cleaning in Place (CIP) of fermenter tanks, recovery, and portable tanks, WPU and flex hoses according to the SOPs or batch records
• Maintained documentation records of all the processes to maintain compliance with Confidential
• Performed pharmaceutical water sampling: Flushing and dispensing WPU
• Performed CIP of the line from media prep to fermentation rooms
• Operated and maintained ON DESK manufacturing equipment: spectrophotometer, peristaltic pump, Vi-cell, pH meter, Dissolved Oxygen meter (DO meter), and Confidential
• Submitted samples through QLIMS for quality control
• Collected sample from fermenters, rinse sample and other sample collection according to batch record
• Worked in Bio Safety Cabinets ( Confidential ) with aseptic techniques by work SOPs
• Ensured proper gowning in Confidential area to maintain GMP requirement in order to reduce chances of impurities to process
• Submitted samples (TOC, conductivity, nitrates, validation sample support, FTIR, etc.) to QC for further analysis if required