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Quality Control Manufacturing

Location:
Lowell, Massachusetts, United States
Posted:
February 21, 2018

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Resume:

Saman Lim

978-***-****

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.



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