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Online Resumes with "Batch Records"



Auditor - 19 Years of Experience - Near 11224

Cover Letter Ignace Vallejo, MS. Sr QA Compliance Specialist. Certified Quality Auditor GMP; by CFPA. 525 Neptune Ave, Brooklyn, NY 11224. Apt 22 F Home # 718 946 0556. Mobile # 917 359 3028. ignaciovallejo@optonline.net To whom it may concern: I am applying for the position of Mgr and Regulatory Compliance. I have 19 years of experience working in the Pharmaceutical Industry. My experienc...

Ideal Companies: Large company

Tags for this Online Resume: QA, QC, Scientist, Auditor, Medical Liaison

Quality Assurance Associate, Sunnyvale

Clinical Quality Assurance Associate

Tags for this Online Resume: Research Associate, Quality Assurance Associate, Batch Record Coordinator

Quality Assurance Specialist - 18 years cumulative quality assurance (QA) experience in the biotech/pharmaceutical (vaccine manufacturing) and environmental monitoring industries. Expertise in QA Batch Record Review and QA Stability.

To continue to develop expertise as a Quality professional in the biotech/pharmaceutical industry.

Tags for this Online Resume: Quality Assurance Specialist, Batch Record Review, Stability, Process Monitoring, Annual Product Review, Product Quality Review, Technical Writing, SOP Revision

Featured Profile

What I know is not taught in college.

Given the experience I have I can be of tremendous value and hit the ground running making a substantial impact in just a few months once I learn and understand your systems.

Ideal Companies: Pfizer, Johnson & Johnson, Idec, Lilly, Custom Processing Services, Waste Management

Tags for this Online Resume: Project Manager, Six Sigma, Team Building, Master Scheduler, Training, Mentor

Clinical Quality Assurance - 16 Years of Experience - Near 30601

A highly efficient, methodical and talented quality assurance analyst who has more than 16 years’ experience in the field of process control, quality and regulatory fields and QA/QC analytical systems. I have considerable experience of developing and implementing effective quality control processes and structures in a manufacturing and corporate environment. Possessing good essentials of safety and quality. Strong customer ...

Tags for this Online Resume: QUALITY ASSURANCE, pharmaceutical, documentation, 21 cfr 210-211, sop, fda, batch record review, audit

Featured Profile

Senior Process Validation Lead

Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.

Director of Quality - 20 Years of Experience - Near 91325

To utilize my Education, professional experience and expertise on pharmaceuticals, Nutraceuticals, and Personal care products to improve productivity and reduce production cost by managing rework, waste control and proper schedule to finish the assign job on time. Extensive practical experience in formulation, Development, Optimization, Scale-up, Validation and tech-transfer activities for the following: *Generic pharmaceu...

Tags for this Online Resume: Director Research and development and production, cGMP, GMP, SOP, CMC, QBD, Quality by Design, scale up, validation, Monitoring, DMF, CTD, drug master file, Injection, parenterals, Lyphilization, Tablets, Capsule, Cosmetics, cream, lotion, gels, softgel, powder for drinks, Liposoms, ethosoms, Sustain Release tablet, control release tablet, Granulation, compression, Coating, Formulation, production, Medical device, Drug loading, drug delivery, Autoclave, ETO gas sterilization, steam sterilization, Heat sterilization, Depyrogen sterilization, Large volume parenteral, small volume parenteral, ophalmic ointment,eye drops,

Featured Profile

Chemical Engineer, Process Engineer, Project Manager

Looking to leave oil and gas for more challenging, sustainable and impactful engineering problems. I want to bring my passion, hard work, education, experience and drive to a team focused company and help make real solutions for today and tomorrow.

Ideal Companies: Tetra Tech, Johnson & Johnson, Ch2m Hill, W. L. Gore, Procter and Gamble, Department of Energy

Tags for this Online Resume: six sigma, detailed oriented, process engineer, project engineer, behavior based safety, microsoft office, organization skills, communicate professionally, bi-lingual, self starter, SAP, hysys - aspen plus, optimization, chemical processes, quality assurance

Pharmaceutical Quality Assurance Specialist- 10 years Experince- Atlanta

Seeking a challenging assignment in Quality Assurance in the pharmaceutical sector to utilize acquired expertise and deliver best-in-class results. PROFESSIONAL SNAPSHOT: •A Quality Assurance Professional bestowed with 10+ years of experience in Corporate Quality Assurance, Plant Quality Assurance, Manufacturing, Validation and different International Quality audits in Solid Dosage. •Hands on experience with Quality Manage...

Tags for this Online Resume: QMS, Batch Record Review, Preparation of SOP, CAPA, Investigation, Change Control, Deviation, Internal Audit, Document Control, Batch Release, Solid Dosage, Process Validation, APQR, Market Complaint, GMP, OOS, Self Inspection, Third Party Audit

Chemist - 15 Years of Experience - Near 07747

SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality...

Tags for this Online Resume: Pharmaceutical, Pharmaceutical Industry, Quality Control Chemistry, Quality Control Chemistry, Quality Control, Accredited Pension Representative, Audit, QC Manager

Plant Operator - 20 Years of Experience - Near 07002

PROFESSIONAL SUMMARY Over twenty years of experience in solid dosage and semi-solid products from lab scale up to clinical production in preparation for transfer to full scale manufacturing. Provide support to R&D product development teams in the operation of equipment Mills, Blender, High Shear Granulators, Tablet Presses, Spray Dryers, Blister Fillers, Tube Fillers, Tray and Fluid Bed Dryers. Experienced with ancillary eq...

Tags for this Online Resume: 5S, Data Entry, Documentation, Management, Manufacturing, Operational Excellence, Training, Hazardous Waste, Research and Development, Scheduling

Electromechanical Equipment Assembler - 1 Years of Experience

SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.

Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control