Saman Lim
ac4j2z@r.postjobfree.com
SUMMARY:
●A highly motivated individual seeking job opportunities in the Biological or Health Sciences fields, offering outstanding laboratory skills within research and data analysis for production industries.
●Experienced in Microbiology Lab with Environmental Monitoring of Clean Room, Maintaining quality Control laboratory records, Bioburden testing on Incoming processed water.
●Specializing in protein purification and refinement of extracellular matrixes as stipulated by Manufacturing Control Procedures (MCPs) in accordance with Standard Operating Procedures (SOPs) in a cGOP manufacturing environment.
EDUCATION
Lowell High, Diploma 2003
Mass Bay College, CIS (Some course taken)
SKILLS
CGMP environment
Microbiological assays
ETQ and PeopleSoft proficiency
Knowledge of manufacturing standards/regulations
MS Office proficiency
In-depth OSHA knowledge
Chemical processing skillfulness
Radioactive material handling
Protein purification
PROFESSIONAL EXPERIENCE
Bio-Techne, Devens MA November 2017 - Present
Quality Control II
Job Responsibilities:
●Participate in environmental monitoring and high purity water monitoring.
●Write and review material specification.
●Authoring of departure (NCMR, Deviations, CAPA, and others.
●Interpret chemical and microbiological test results to be able to create CofA.
●Execute daily calibration and quality control testing of laboratory instrumentation prior to utilization in manufacturing or QC processes.
●Perform chemical component sampling and obtaining use of hand measurement instruments.
●Conduct Final Quality Control testing for all products using instrumentation to verify process and product compliance to specifications.
●Participate in instrument validations including but not limited to; writing protocols and reports, taking responsibility to see validations through to completion.
●Write and update Standard Operating Procedures via the change order process to remain current with accepted practices and process improvement implementations.
Corning Life Science, Bedford MA 01730 Jan 2008 - Jun 2017
Senior Biologic Technician
Job Responsibilities:
●Train and certify personnel in proper aseptic technique and sterile gowning procedures.
●Assist R&D with assay to determine quality of new products.
●Assays all finished goods to determine the quality of the products before shipping out to custom.
●QCN and Deviation on missed procedure and or alter of any procedure during the manufacturing of the products.
●Ensures that the schedules are correctly implemented and that jobs are completed properly and on schedule.
●Performs technical review and approval of Quality Control laboratory records.
●Reviews Quality control record for method or procedure adherence, calculations and usage of instruments/equipment.
●Performs approval of lot data and record in ERP system.
●Implement improvements and streamlined process.
●Follows all laboratory policies and procedures adheres to all health and safety standards.
●Gram stain failed finished product to identify bacterial with crystal violet, iodine, de-colorization and gram safranin.
●Audit weekly 5S to help eliminate waste, organize the workplace, streamline procedures and establish clear, visual standards.
●Microbiology testing for Bacti/Fungu in cell culture using fluid thioglycollate medium and tryptone soy broth..
●Radioactive, Fluorescent, and BCA Assays.
●LAL Pyrogen Testing: Kinetic Turbidometric.
●Biotest Standard RCS Air Sampler for Viable Microbial, yeast and fungal elements.
●Bioburden testing on Incoming processed water and colony counting.
●Growth Promotion Testing/Sterility of Media.
●Plate Count on Incoming Process Water.
●Environmental Monitoring of Clean Room.
●Participate in a variety of projects designed to improve the service, quality, and efficiency of the media prep team.
Biological Technician
Job Responsibilities:
●Filtration, to separate soluble contaminants remaining with the supernatant.
●Electroporation
●Cell culture by thawing, passing, expansion, and maintenance of 293-Freestyle cell lines.
●Specializing in protein purification and refinement of extracellular matrixes as stipulated by Manufacturing Control Procedures (MCPs) in accordance with Standard Operating Procedures (SOPs) in a cGOP manufacturing environment.
●Mouse Tumor bioburden testing to determine the bacteria on tumor.
●Siliconizing Tube Procedure for pre-treatment to the vials before being utilized for product, to reduce non-specific binding of protein to the vial walls.
●Operating balances, filtration equipment, use of aseptic techniques, water system, laminar flow hoods, pH meters and laboratory equipment.
●Prepare cell culture media, buffers, reagents and solutions under GMP condition .
Sterile Processing
●Autoclave lab wares.
●Maintains inventory of glasswares and glass-washing supplies; orders and replaces item as needed.
●Handle bio hazard waste for decontamination.
Medtronic, Danvers MA 01923 2004 - 2005
Assembly Technician
Job Responsibilities:
●Reads work orders, follows production drawings and sample assemblies, or receives verbal instructions regarding duties to be performed.
●Accurately complete all essential documents (i.e., Lab Notebooks, Device Master Records (DMR’s), Lot History Records (LHR’s), Inspection Records and Validation Documentation).
●Positions and aligns parts in specified relationship to each other in fixture or other holding device.
●Crimps, stakes, screws, bolts, cements, press fits, or perform similar operations to join or secure parts in place.
●Performs adhesive bonding and leak testing.
●Adjusts and trims materials from components to achieve specified medical or dimensional characteristics.
●Performs online testing and inspection to ensure parts and assemblies meet production specifications and standards.