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Online Resumes with "Deviations Investigations"
Microbiologist - 10 Years of Experience - Across U.S.
Looking for a pharmaceutical, biotech or medical device role as a microbiology lead or team leader, or working in a remediation project involving environmental contamination or product testing. Also looking for a non-conformance owner position (deviation investigations).
Tags for this Online Resume: Compliance, Manufacturing, Packaging, Troubleshooting, Data Management, Management, Quality, Quality Assurance, Quality Control, Support, pharmaceutical, protocol, sas, Microbiology, Biopharma, contract, Environmental Monitoring, CAPA, Non-conformance, remediation, Microbial testing, Microbiology team leader, microbiology supervisor, parenteral, aseptic processing, ISO 14644
Air Force - 20 Years of Experience - Near 95687
Summary of qualifications: Twenty five plus years' experience in supervisory/management of personnel and processes from Aircraft Maintenance to Pharmaceuticals. Document work deficiencies when required. Compile data for trend analysis and reporting. Excellent computer skills. GMP, raw materials testing, Deviation Investigation, supervisory and administrative skills include the ability to select, appraise, motivate and devel...
Tags for this Online Resume: Manufacturing, Pharmaceutical, Process Improvement, Test, Distribution, Quality, Quality Assurance, Trend Analysis, Administrative Skills, Avionics
Plant Operator - 20 Years of Experience - Near 01510
SUMMARY Technical leader with extensive experience in an cGMP FDA regulated industrial manufacturing setting. Committed to safe work practices, quality systems, customer service and compliance for the support of operational activities. Proactive, accountable and collaborative team player. Active member of many highly successful cross functional teams. Proven ability to prioritize and coordinate effectively. ACCOMPLISHMENTS ...
Tags for this Online Resume: Documentation, Automation, Compliance, Customer Service, Lean Manufacturing, Management, Manufacturing, Power (Os Enhancemnt Tool, Preventive Maintenance
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
Microbiologist
PROFESSIONAL SUMMARY * Experienced Compliance Reviewer, Quality Control and QA Specialist. * Manufacturing professional with 17 years in GMP controlled manufacturing suites and lab environment seeks a position offering professional growth and stability. * Thrive in challenging environments and am always seeking new ways to improve workplace efficiency. * Skilled in validation of laboratory instruments including those with c...
Tags for this Online Resume: Test, Manufacturing, Quality, Quality Assurance, Quality Control, Documentation, High Performance Liquid Chromatography (HPLC), Pharmaceutical, Software, Compliance
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
