
marianna kozok
qc analyst ii
About
QC Analyst currently working in QC laboratory in a pharmaceutical start-up company. Qualified in Biopharma Science with 5 years cGMP/cGLP industry experience in medical devices/pharma/biotech start-ups, in FDA/HPRA regulated environment. Experience gained: QC routine and non-routine testing (bioassay, ELISA, Karl Fischer titration, GC, fluorescence and UV-VIS spectroscopy), mammalian cell culture, aseptic technique, validation, test method development, audit preparation, cleanroom manufacturing.
ireland
ireland
pharmaceuticals
gmp, fda, sop, cell culture, bioassay, quality control, glps, quality oriented, result oriented, analytical skills, biotechnology, quality system, laboratory, validation, iso, manufacturing, inspection, capa, change control, reagents, medical devices, asseptic technique, reagent preparation, data review, equipment maintenence and calibration, receiving inspection, attention to detail, analytical approach, results focused, iso 13485, mammalian cell culture, pharmaceutical industry
Experience

qc analyst ii
regeneron pharmaceuticals, inc.
Get in the Ideas Business.At Regeneron we believe that when the right idea finds the right team, powerful change is possible.As we work together to discover, invent, and develop biopharmaceutical medicines, we're creating whole new ways of thinking about science, manufacturing and commercialization. And whole new ways of thinking about health.So connect with us. Tell us about you. Learn more about our life-changing medicines. And join us, as we build a future we believe in.Please visit www.regeneron.com/social-media-terms for more information on how to engage with Regeneron on social media.

production associate
dell
* Manufactured notebooks and desktops to ISO quality standards. * Participated in Kaizen project - suggested improvements in the manufacturing area in regard to production process, quality and health and safety. * Trained in new employees.

quality control analyst
olympus biotech
* Performed bioassay potency testing for batch release and stability, maintained cell lines, prepared media and reagents. * Trended and reviewed test data. * Scheduled and performed routine cleaning. * Maintained laboratory stock of reagents and consumables. * Scheduled preventive maintenance visits. * Performed periodic review of SOPs. * Provided Quality Control support to Operations Department.

manufacturing team member
cordis
* Manufactured Nevo drug-eluting coronary stents in cGMP FDA regulated environment in ISO Class 8 clean room. * Set-up, adjusted, operated and troubleshot stent mapping and filling equipment. * Accurately completed production documentation and log books. * Maintained up-to-date SOPs and batch records. * Trained new hires and cross trained emploees.

qc scientist 1
ethicon, inc.
* Participated in start-up activities: equipment validation, operation and maintenance; test method development and validation; writing, execution and reporting of IQ/OQ/PQ protocols. * Prepared QC Laboratory for internal and regulatory bodies audits and maintained audit readiness. * Managed QC samples and reported test results using eLIMS. * Performed QC testing of process development, qualification and validation samples. * Trained other scientists in test methods and work instructions as required.
Education
staffordshire university
forensic science
university of limerick
engineering
medical college in koszalin, poland
Work experience in the Hosptal Laboratory of Clinical Pathology and Microbiolgy, (1997-1998).
west pomeranian university of technology in szczecin
animal science
Master's Thesis titled: ‘Effect of Captopril on Potassium and Magnesium Concentration in Red Blood Cells in Calves during the First Week of Life’, 2003. Article Published: Ozgo M., Skrzypczak W.F., Kozok M.: Effect of Captopril on Potassium and Magnesium Concentration in Blood Plasma and Erythrocytes of Calves during the First Week of Life. Acta Scientiarum Polonorum, Medicina Veterinaria 3(1) 2004, 125-133 Other Work Presented: ‘Effect of Angiotensin Converting Enzyme Inhibition on Blood Pressure in Neonatal Calves’, Student Science Conference, Szczecin 2002 Activities and Societies: Animal Physiolgy Students' Science Club - 2002 - 2003. Participated in research on kidney physiology, water-electrolyte balance and hormonal and pharmacological regulation of renal function in neonatal calves.
west pomeranian university of technology in szczecin
animal science
Work Presented: ‘Plasma Renin Activity and Aldosterone Concentration during Perinatal Period in Cows’, Student Science Conference, Szczecin 2000 and International Students Science Conference, Wroclaw 2001 Activities and Societies: Animal Physiolgy Students' Science Club - 2000 - 2002. Participated in research on kidney physiology, water-electrolyte balance and hormonal and pharmacological regulation of renal function in neonatal calves.
marianna kozok's Contact Information
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