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Title Quality Control Assurance
Target Location US-PA-Philadelphia
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Phone: PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLELINKEDIN LINK AVAILABLEProfessional Summary17 years of experience in performing Microbiology, Quality Control, Quality Assurance, Internal Audit, Deviation Management, Environmental Monitoring, Batch Records, CCP Monitoring, Aseptic techniques, GMP, GLP, SSOP, HACCP, ISO, BRC, USP, FDA and Record Keeping(LIMS).EducationMaster of Science(M.Sc) in Microbiology, Mar 2003Bharathiar University, Tamil Nadu, India.(Assessed and approved by UK NARIC)Bachelor of Science(B.Sc) in Microbiology, Mar 2001Periyar University, Tamil Nadu, India(Assessed and approved by UK NARIC)Technical SkillsFully Proficient in Windows and MAC Operating Systems.Thorough working knowledge of all versions of Microsoft Word, Excel, PowerPoint and Office365.Employment HistoryAstraZeneca June 2023 - PresentPhiladelphia, PA, United StatesRole: Quality Control Laboratory SpecialistAstraZeneca is a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.Duties and Responsibilities at AstraZenecaCollect environmental monitoring samples including particulate, viable surface, air samples and utilities samples.Conduct Microbiological assays and tests.Perform Bioburden, Bacterial Endotoxins, Nitrates, TOC etcAccurately complete laboratory data forms, logbooks, batch records and other required.Prepare documentation according to and in compliance with GMPs and SOPs.Report results of ongoing tests to management.Perform documentation for investigation reports.Review and track deviations, CAPA's, and investigation reports.Viceroy Exports India Pvt Ltd. June 2013  Dec 2022Mangalore, Karnataka, IndiaRole: Quality Assurance Manager/TechnologistViceroy Exports Pvt. Ltd. is a leading Sea food exporting company with its corporate base in Kochi, India. Established in the year 1999. This company is being assessed and approved by the Export Inspection Council of India.Duties and ResponsibilitiesMicrobiological quality assessment of frozen fish and fish products.Supervise laboratory and plant staff.Conduct analysis and initiative corrective measures.Investigate all issues and prevent any GMP problems on samples.Determine the Critical Control Points (CCPs).Establish corrective action when CCP is not under control.Establish documentation and record-keeping.Internal auditing and training staff.Reviewing customer requirements and making sure they are met.Working with purchasing staff to establish quality requirements from external suppliers.Devising and establishing a company's quality procedures, standards and specifications.Reporting of anomalies or subsequent rejections observed in incoming materials, finished goods, on production floor, in dispatch section.Preparation of SOPs, Revising HACCP manual and making training module for staffsTo study and implement the changes as per EIA, FSSAI, USFDA BAM, etc.Responsibility to conduct Internal Audits, Issue internal laboratory reports etc.Online process check & to take corrective action against any discrepancy being observed.Updating Products, process through R&D work and updating of hygienic standards.Coordinating with the External test laboratory to obtain the external lab report as per requirement of ISO, FSSAI, EIA & IOPEPCFiling and maintenance of records, maintenance of instruments, stock maintenance,Calibration of instruments, QC logs, setting standards for quality as well as health and safety.Making sure that manufacturing or production processes meet international and national standards.Looking at ways to reduce waste and increase efficiency.Making suggestions for changes and improvements and how to implement them.Making sure the company is working as effectively as possible to keep up with competitors.Shift schedules of the staff and leave management.Blue Water Food and Exports. Feb 2012  July 2013Mangalore, Karnataka, IndiaRole: Microbiology TechnologistBluewater Foods And Exports Private Limited is a Private incorporated on 21 March 1997. It is involved in Wholesale of agricultural raw material, live animals, food beverages and tobacco.Duties and ResponsibilitiesMicrobiological quality assessment of frozen fish and fish products.Supervise laboratory and plant staffs.Conduct analysis and initiative corrective measures.Investigate all issues and prevent any GMP problems on samples.Determine the Critical Control Points (CCPs).Establish corrective action when CCP is not under control.Establish documentation and record-keeping.Internal auditing and training staffs.Stansted Laboratories. Oct 2007  Dec 2008Essex, London, United KingdomRole: Water AnalystStansted Laboratories is UKAS accredited and operates both microbiological and chemical laboratories, specialising in legionella and bacteriological testing of drinking and stored water.Duties and ResponsibilitiesMicrobiological analysis of water samples using a variety of techniques such as aseptic technique, plating, bacterial identification and preparing media.Record all work in technical notebooks and report results.Calibrate and maintain certain laboratory equipment and undertake microbial culturing.Ensure that internal QC schemes are implemented in the laboratory results are monitored on a daily basis.Perform general laboratory work using aseptic techniques.Alcontrol Laboratories. Oct 2006- Oct 2007Slough, Berkshire. United KingdomRole: Analyst-MicrobiologyALcontrol laboratories is one of the largest environmental (water, land & air) food and oil analysis organisations in the UK and Ireland.Duties and ResponsibilitiesIsolation and identification of microorganisms such as Legionella, E-coli, Coliforms, F-streptococcus, S-aureus, Pseudomonas, Campylobacter, Yeast and mould.Prepare all equipment and media requests for the lab and to maintain autoclaves in good working order.Quality control testing of mediaMaintenance of stock levelKeep records in accordance with GLP standards.Assist in investigations conducted in the microbiology section.Prioritise sampling depends on the requirements, staffing levels and quality problem.Aware of, and conform to the Quality system, and the associated quality control checks carried out by the laboratory.Assist in the training of new employees as required.Carry out any reasonable duties as specified by the line manager.Eurofins Scientific Limited. Jan 2005 Oct 2006New Cross, London, United KingdomRole: Microbiology Lab Technician.Eurofins Laboratories Ltd is a life sciences company operating internationally to provide a comprehensive range of analytical support services drawing on the latest developments in biotechnology. The Group specialises in delivering analytical testing services to clients from a wide range of industries including the pharmaceutical, food and environmental sectors.Duties and ResponsibilitiesAnalysis of food and water samples using aseptic techniques such as membrane filtration of water. Analytical Techniques in the isolation of the following organisms: Salmonella sop, Listeria sop, E.coli, Campylobacter, F-streptococcus, B-cereus, S-aureus, C-perfringens, Legionella, Yeast and Mould.Maintaining quality control of media.Equipment monitoring and calibration.Preparation of media.Training of new staffMonitoring laboratory recordsAnalysis and interpretation of resultsSample examination, photography and report writing.Inverted and non-inverted sugar analysisMoisture analysis and pH analysisCertificationHazard Analysis and Critical Control Point (HACCP)Sanitation Standard Operating Procedures (SSOP)International Organization for Standardization (ISO)ExplorerFully proficient in Office Reprography.Fully proficient in all work-related softwareAdditional SkillsGood teamwork capabilities with the added ability to lead and motivate teammates.Good people skills with the added quality of efficient communicative skills.Strong team player, needing minimal supervision, bringing enthusiasm and commitment to achieving objectives.Successfully prioritising and managing a variety of tasks and projects simultaneously using excellent organisation and administrative skills.Special SkillsFluent in English, Tamil, and Malayalam. Average listening comprehension of spoken Hindi. Minimum comprehension of spoken Spanish and Kannada.

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