CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "batch record review"

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

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

Biologist - 15 +Years of Experience - Near 33759

PROFESSIONAL PROFILE Solid experience in QA Regulatory Compliance world class companies. Interested in a challenging position with focus in QA Systems and Manufacturing operations fields. Broad knowledge in cGMP, ISO, EPA, DOT, FDA, and ANSI ASQC regulations. Working knowledge in sampling, inspection, and disposition processes, SPC, Change Controls, NC/CAPA, Validations, and Calibration systems. Highly organized, enjoy cha...

Tags for this Online Resume: Compliance, Documentation, Packaging, SPC, Test, Management, Quality, Quality Assurance, Quality Management, Assessments, pharmaceutical, sap, protocol, SOP, Validation, NC, CAPA, Change Control, Regulatory, Audit, GAP Assessments, Calibration, Raw Material, Incoming Inspection, Batch REcord Review, Classified Clean Rooms, Investigation Reports, Disposition, REserve Samples Program

Chemist - 2 Years of Experience - Near 27513

SUMMARY * * Goal-oriented with strong analytical, problem solving, and writing abilities. Experienced in a number of chemical quantification and characterization techniques including FTIR, fluorescence spectroscopy, TGA, HPLC, UV-vis, and GC-MS systems as well as Quality Assurance skills such as data review, batch record review, and the drafting of cGMP documentation including SOPs and Master Batch Records.

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Documentation, Manufacturing, Pharmaceutical, Quality Assurance

Quality Coordinator - 20 Years of Experience - Near 18353

Areas of Expertise & Technical Skills * Regulation Compliance * Agile (Scrum Master) * Internal/External Audits * Batch Record Reviews * CAPA / Risk Management * QA System Management & Implementations * Project Life Cycle * Technical Writing * Process Improvements * Six Sigma (Green Belt) * Document Controls * Software Implementation * CFR 210/211/820/803/58/11 * Team Training & Development

Tags for this Online Resume: Audit, Business Contingency Planning, Compliance, Documentation, Good Manufacturing Practices, Manufacturing, MDR, Packaging

Biochemist - 18 Years of Experience - Near 21224

QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...

Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical

Quality Manager - 16 Years of Experience - Near 00693

Profile Excellent team work and versatile person with a Bachelor Degree in Science and over ten years of experience in the Pharmaceutical, Diagnostic and Biotechnology industry, including: Quality Assurance (QA) and Manufacturing. Able to administrate computer systems, identifies and evaluate compliance issues. Experience with start-up Projects in the quality and manufacturing areas. Proven leadership capabilities coordinat...

Tags for this Online Resume: Quality, Manufacturing, Quality Assurance, Product Release, Audit Process, Batch Record Review, Test, Diagnostics, Inventory, Media Preparation

Clinical Quality Assurance - 15 Years of Experience - Near 03811

Tags for this Online Resume: Complaints, Documentation, Pharmaceutical Industry, Quality, Quality Assurance, Quality Control, Risk Analysis, Test, Compliance, Kaizen, trackwise, batch record review, CAPA, deviations, audit, VEEVA

Chemist - 20 Years of Experience - Near 84341

Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...

Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface

Machine Operator

COVER LETTER: Dear Hiring Manager, With response to your advertisement in Monster.Com, I am applying for the post of Manufacturing Technician Chemist in your organization, I am in the biopharmaceutical manufacturing industry for more than thirteen years now and I have exceptional technical knowledge. I am confident that my candidacy will surely exceed your expectations. As a team lead and OJT trainer, I have handled many im...

Tags for this Online Resume: 5S, Corrective Actions, Manufacturing, Pharmaceutical Industry, Root Cause Analysis, Team Lead, Troubleshooting

Quality Coordinator - 5 Years of Experience - Near 08817

PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...

Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting