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Online Resumes with "Deviations Investigations"



Featured Profile

Quality Assurance Manager

I would like to pursue a Quality Assurance manager position utilizing my knowledge and experience in the Biotechnology and Pharmaceutical industry and develop or enhance existing Quality Systems. The ideal position would provide the opportunity for me to use my people skills, problem solving and creativity to meet both internal and external customer needs.

Tags for this Online Resume: quality, technical writing, compliance, cGMP, Process consultant

Quality Assurance Manager, Auditor

Professional Scientist with extensive experience in quality control, quality assurance, auditing and regulatory compliance. Expertise in deviation, investigation, CAPA and method/specification development. In-depth knowledge of FDA and ICH regulations. Proven track record of hiring, coaching, motivating, empowering and managing people. An excellent communication, leadership and conflict management skills with ability to org...

Tags for this Online Resume: quality assurance, deviation, investigation, CAPA, LIMS, cGMP

Laboratory Supervisor

24 years in Pharmaceuticals as a scientist/chemist.

Ideal Companies: Dupont, Invitrogen

Tags for this Online Resume: laboratory supervisor, Chemist, Cleaning Validation, Validation, Protocol, Risk management

Validation, Quality

Seeking employment in a professional atmosphere where to succeed in the implementation of Quality, Operational, Validation methods following the company's general Manufacturing goals.

Clinical Supplies-Project Management -Quality Assurance

I'm a clinical supplies professional who has 33 years experience in end to end clinical supply chain project management, coaching and mentoring team members with respect to quality system compliance to process and GMP, root cause analysis, deviation investigation, CAPA lifecycle. Expertise in Visio, MS Project, Powerpoint, excel and word.

Tags for this Online Resume: Trackwise, clinical trial materials, Annex 13

Featured Profile

SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL

Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...

Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)

Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor

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

Microbiologist - 9 Years of Experience - Near 07016

Qualifications: * Proven abilities as a laboratory technician and experienced microbiologist, with skills in analyzing, defining, establishing, and meeting goals and objectives. Experienced cross-functional player that works well with others to execute established guidelines. Keen ability to plan, organize and direct projects and special tasks. Known abilities to interact with people of diverse ethnic and economic backgroun...

Tags for this Online Resume: Pharmaceutical, Media Preparation, Audit, Inventory, Quality, Quality Assurance, Quality Control, COLI, Microbiology, Data Entry

Quality Manager - 11 Years of Experience - Near 07077

Areas of expertise: Product Development - Outside Sourcing - Vendor Relation Interaction - Suppliers Interactions - Management - Personal Development Growth of Team Members- Quality Systems Consultation - Strategic Planning - Deviation Investigation - FDA Compliance - Root Cause Analysis - Budgeting Needs Assessment - Customer Service - Process Improvement & Optimization -Quality Assurance -Project Management - Audits Produ...

Tags for this Online Resume: Packaging, Quality, Forklift, OSHA, Toxicology, Management, Audit, Compliance, Computer Aided Software Engineering, Documentation

Biochemist - 15 Years of Experience - Near L4J 7

Summary 5 years of biotech scientist in Canadian pharmaceutical industry, 10 years of academic research experience in US and Canada, 4 years of medical executive in a US-owned biotech company in China . Identification, Verification and QC analytical tests following cGMP or GLP * Perform Quality procedures such as Change management, Deviation investigation etc. * Calibration and validation of data and instruments * ELISA bas...

Tags for this Online Resume: Research, Management, Medical, Protocol, Banking Industry, Biotechnology, Clinical Research, Construct (App Dev Tool), Dec, ELISA

Clinical Research - 20 Years of Experience - Near 11554

SUMMARY Extensive management and technical experience with pharmaceutical companies in the areas of Quality Assurance, Quality Control, Manufacturing Support and Product Development. Back ground includes: * Risk Management * Process Improvement Projects * Clinical Investigator Site Audits GCP/GMP/PV Internal/ External Audits * Documentation audits * GMP, GCP Deviations/Investigations Change Control Management * Complaints H...

Tags for this Online Resume: Budget Preparation, Budgeting, Test, Compliance, Good Clinical Practices, Documentation, Technical Documentation, Packaging, Process Improvement