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Online Resumes with "GMP compliance"



Director- Global Operations- 20+ years of experience- Manufacturing of Biologicals-Technical Transfer-develop people-GMP compliance-Regulatory submissions-

Expertise in managing Supply chain for a 1.5 Billion dollar Medical Device Reagents business. Technical, Quality and Regulatory background to manage the business under FDA compliance.

Ideal Companies: Johnson and Johnson, Celgene, Sanofi, Novo Nordisk, Bristol-myers Squibb,

Tags for this Online Resume: Manufacturing Biologics, Protein Purification, Microbial Fermentation, CGMP, FDA Compliance, Protein Characterization, Quality Control, Regulatory Submissions, Quality Audits, Six Sigma Black belt

Featured Profile

Quality and/or Safety Manager

I am a highly accomplished science professional who would like to use my 15 years of experience designing and implementing Quality Systems and Environmental Health & Safety Programs to manager a companies facilities and/or product quality, regulatory and safety compliance. I can leverage my extensive knowledge of quality and safety systems to manage all levels of both product and process implementation including, documentat...

Ideal Companies: Ideal companies I would like to work for will be in the science and technology sector within a 30 mile radius of zip code 06405. Examples of large companies include Covidein (North Haven), Phillips (Meridan), Perkin Elmer (Shelton), Unilever (Trumbull), BMS (Wallingford). Smaller companies are concentrated in Wallingford, Meridan, Milford and New Haven. Yale, Southern Connecticut State, and Quinnipac Universities are also potential opportunities.

Tags for this Online Resume: Quality Assurance, FDA Compliance, EHS Management, Strategic Planning, Research and Development, Operations Management, Project Management, Cross-Functional Leadership, Technical Support/Writing, Customer Satisfaction, Continuous Process Improvement, Team Building/Training and Mentoring

Quality Coordinator - 20 Years of Experience - Near 28590

Looking for a job in Quality using my varied background. Want to bring my experience to a company where I can grow my knowledge and be a part of a growing team. I enjoy detailed work and am very organized. I am skilled in multiple IT applications, Documentum, MS Office, SAP, and TrackWise. I would be interested in relocation in the Southeastern area. Also I can travel and have a valid passport.

Tags for this Online Resume: Quality, Change Control / Change Mgmt., cGMP / Compliance, Records Retention, EDMS / Document Mgmt. , Training /Course Development / LMS, Auditing, MS Office Apps / TrackWise / SAP

Biochemist - 10 Years of Experience - Near 66502

Seeking employment in a meaningful role in which I can do significant and important work. I am creative, thoughtful, diligent, and ambitious. I have had a great deal of success fixing problem processes and solving various issues as they relate to production, science, engineering, and manufacturing.

Tags for this Online Resume: cGMP compliance, Molecular Separations, Microbiology, Food Scientist, Biochemist, Process Engineer, Analytical Chemist

Featured Profile

Chemist - 20 Years of Experience - Near 33411

I am a Quality Assurance professional with over thirty years of experience in Quality Assurance in the Pharmaceutical, Biotechnology and Medical Device Industry.

Ideal Companies: Medical Device or Pharmaceutical Companies

Tags for this Online Resume: Failure Investigation, Corrective Action, Preventive Action, Training, cGMP's, Florida, Auditing, pharmaceutical

Manager - 20 Years of Experience - Near 19038

Project Management | Procurement Management |Quality Assurance Project Management: Successful Project Manager with 10+ years of experience in the pharmaceutical industry commercializing over-the-counter new products and line extensions. Proven career record of producing multi-million dollar profits through the leadership of cross-functional teams and strategic identification and implementation of cost savings and effective...

Tags for this Online Resume: Project Manager, Philadelphia, Administrator, Analyst, Purchasing, Operations, Pharmaceutical, Self motivated

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

Featured Profile

Vice President - 20 Years of Experience - Near 79902

Seeking a position as Director, Vice President, President or General Manager in a company expanding in LATAM. I am a results oriented international executive with a proven track record of leading and transforming organizations with 25+ years experience in operations and technology transfers in the medical device, aerospace, nuclear and energy sectors.

Ideal Companies: SpaceX, Tesla, Boeing, Bombardier, Medtronic. Companies Expanding in Mexico or LATAM. Aerospace, medical, manufacturing, new technologies

Tags for this Online Resume: Manufacturing, Mexico, Medical , Aerospace, VP, Vice President, Operations, Sales, LATAM, Director, General Manager

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

Program Manager - 12 years Experience- Milford, CT

CAREER SUMMARY Edgewell Personal Care (Formerly Energizer Personal Care), Milford, Connecticut Program Manager (2015 to July 2016) * Managed all internal and external requirements for the Program, including financial, safety, quality, resources, compliance with external government regulations to transition all global product packaging from Energizer to Edgewell Personal Care. * Managed cross-functional team of twenty-five c...

Tags for this Online Resume: Medical Devices, Quality, Documentation, Engineering, Packaging, Quality Assurance, Surgery, Training, Program Manager, Budget, Logistics planning, Consumer Goods Industry, Regulatory, FDA, GMP compliance, MS Project, Excel, Green Belt Six Sigma training, certified ISO 9001 auditor, MBA

Senior Manager / Director of Quality

Summary of Qualifications: * Twenty Eight +, years of experience in molecular biology, protein chemistry, biotechnology sciences, QC management, Regulatory Affairs, and Quality Assurance. * Experienced in establishing and directing groups, project management, assay development, personnel training and supervision, quality control, and regulatory cGMPs. * This combination of skills affords a unique opportunity to guide the Qu...

Tags for this Online Resume: Audit, Compliance, Biotechnology, Due Diligence, Licensing, Insurance, Microbiology, Benefits, Documentation, Chemistry

Clinical Research - 9 Years of Experience - Near 38654

Career Summary Pharmacovigilance Director of consumer care division with an in-depth knowledge of Food and Drug Administration (FDA) regulations governing the reporting of adverse events and experienced in a GMP, compliance-driven environment. An articulate and positive communicator with proven effective management of staff, workload, vendors and associated processes to maintain exceptional quality, consistency and complian...

Tags for this Online Resume: Documentation, Management, Regulatory Affairs, Compliance, Integrate, Outsourcing, Quality, Risk Management, Triage, Audit, pharmaceutical, regulatory, Drug safety, clinical trials, research