- 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
System Lab Engineer, Devens, MA
- 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.
Quality control specialist, Andover, MA
- 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
Quality assurance specialist, Somersworth, NH
- 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.
Manufacturing Associate, Portsmouth, NH
- 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.
Repository Technician, Rockville, MD
- 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
Manufacturing associate, Rockville, MD
- 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