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Quality Control Analyst

Location:
Methuen, MA
Salary:
22.00
Posted:
May 01, 2016

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Resume:

Medtronic, Danvers, MA

QC Incoming Inspector

Nov 2015-April 2016

Perform mechanical and visual inspections on incoming, in-process and final product.

Calipers, height gages, optical comparator and micrometers.

Released catheters and extruded products.

Genzyme, Woburn, MA

QC Lab Tech

July 2015-Nov 2015

Perform Viscosity Testing, Percent Solids and Particle Size.

Incoming Inspection on all raw materials.

Reviewed and released Incoming and Finished Goods.

Final Inspection of kits, labels and inserts.

Ferro Ceramics, Wilmington, MA

QC Lab Inspector

Dec 2014-March2015

CMM (Mitutoyo)-vision and touch. Ran variety of programs.

Perform Mechanical and visual inspections on incoming, in-process and final product.

5S the Lab and Continuous Improvement.

First Article Inspection.

Used calipers, height gages, optical comparator and micrometers.

Micron, Fitchburg, MA

QC Lab Tech

Sept 2014-Dec 2014

Ability to read prints and have knowledge of geometrical tolerance.

Responsible for preforming dimensional measurements and visual inspection.

First Article inspections of new parts and sample runs.

Incoming Inspections and used optical comparator to inspect small parts.

Keurig, Burlington, MA

Lab Tech –Metrology Lab

May 2014-Aug 2014

Inspected – incoming raw material, in process and finish goods.

Used calipers, multimeters, height gages, and micrometers.

CMM (Hexagon)-vision and touch.

Conducted gage R&R studies for new and existing quality control measurement systems.

Beckman Coulter, Danvers, MA

QC Analyst

Apr 2013-March2014

Perform inspection and functional testing of incoming reagents, finish good products and kits.

Ensures product performance meets published standards.

Automated Equipment Runs: Biomek, SPRI-TE and qPCR790/ Genomics for qPCR related assays.

Recommend accept/reject for discrepant product, change orders, and product labeling.

Coordinate the activities for generating and sending out C of A.

Properly document quality testing data and paperwork to relay information.

Maintaining Workplace Order.

Enzymatics, Beverly, MA

QC Analyst, Manufacturing-Kitting

Dec 2011- June2012

Worked in the Kitting area to ensure maintenance, and execution of quality control procedures to comply with ISO 13485 and 21 CFR 820 regulations.

Maintain QC program as developed and implemented new procedures as necessary.

Participated in production build and QC inspections activities as needed.

Worked with Management to ensure that QC is built into the program at every step of the process.

Bristol-Myers Squibb, Devens, MA

QC Analyst, QC Chemistry - Sample Receipt (Contract)

Jan 2011-Apr 2011

Coordinated all sample receipts, logging, tracking, storage, distribution and archiving of samples.

Maintained up to date knowledge of cGMP, job related SOPs and ensured training requirements were current.

Performed USP/EP TOC, conductivity, and nitrate testing for the laboratory.

Monitored processes and results recommending method improvements to enhance organizational structure.

Improved productivity across multiple departments by reorganizing the storage area where samples were stored and implemented streamlined procedures allowing samples to be retrieved quicker.

AstraZeneca, Westborough, MA

QC Analyst, Analytical Lab

May 2004-Oct 2009

Tested Active Ingredients using HPLC for concentration of Pharmaceutical Grade Drugs.

Analyzed QC samples used for testing, documenting results, trends, and anomalies.

Effectively planned, prioritized, and scheduled testing activities to maximize use of resources and meet key laboratory objectives.

Knowledgeable of FDA guidelines required for laboratory operation, and to accomplish required QC tasks.

Performed updates on laboratory Standard Operating Procedures to reflect improvement and FDA guidelines.

Expertly calibrated and troubleshot testing equipment monthly to ensure compliance with analytical laboratory processes at all times.

Maintain, troubleshoot, investigate lab equipment to reduce recurring problems and improve throughput and cycle time.

Technical Skills

qPCR • BL2 Lab• Dissolution • Drug-Coated Stents • Viscometer • Colorimeter • HPLC

Gel Electrophoresis

Karl Fischer • GC / IR / UV Vis • Particle Size • Nanodrop Analysis

TotalChrom • SmartLab/Lims/ Oracle

Education

B.S., Food Science, University of Rhode Island



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