CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "Warning Letters"

General Manager - 14 Years of Experience - Near 35226

Qualifications Profile Multifaceted, success-driven, and top-performing professional, offering hands-on experience in operations management, business development, and project oversight to fully utilize well-honed skills and expertise within diverse industries. Known as strategic manager and effective leader with strong ability to integrate innovative concepts and ideas develop innovative and cost-effective solutions and spe...

Tags for this Online Resume: Audit, Filing, Payroll, Purchasing, Management, Quality, Training, Accredited Pension Representative, Back Office, Budgetary

Experienced Director of QA/Validaiton - 15 Years of Experience - Near 27587

Tags for this Online Resume: Validation, Software Validation, GMP, 21CFR, 21CFR PART11, Aseptic Processing,, CAPA, Quality Systems Management, Change Control, Compliance Enhancement, Warning Letter Remediation, Deviation/Exception Management,

Administrative Assistant - 20 Years of Experience - Near 21229

A project manager combining over twenty years' experience with a passionate commitment to developing businesses and teams to meet changing technical and structural needs of the field. An experience of a variety of roles throughout the sector has allowed for the building and advancing of knowledge and skills including team management leadership project management knowledge of federal funds finance management and a variety of...

Tags for this Online Resume: Computer Aided Software Engineering, Imaging, LMS, Medical, Referrals, Vista, Quality, Quality Assurance, Quality Control, Support

Quality Assurance Director - 20 Years of Experience - Near 33545

BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...

Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance

Quality Manager - 20 Years of Experience - Near 00736

SUMMARY OF QUALIFICATIONS Pharmaceutical Industry professional with over 22 years of progressive experience in functions related to Manufacturing, Quality Assurance, Compliance and Regulatory areas. Extensive knowledge of chemical and pharmaceutical plant operation, with experience in aseptic, parenteral, aerosol, lyophilization and solid dosage processes. Hands-on experience operating under Warning Letter environment, impl...

Tags for this Online Resume: Audit, Pharmaceutical, Internal audit, Manufacturing, Test, Packaging, Assessments, Complaints, Management, manufacturing

Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry

PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...

Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device

Aerospace Engineer - Near 85055

Seeing a Senior Executive Role in a solid company with a bright future.

Tags for this Online Resume: Change Agent, Lean Six Sigma, Warning Letter Remediation, Turn Around, FDA Expert, Senior Executive, Vice President Operations, vice President Quality Assurance, Vice President Regulatory Affairs, Chief Operating Officer, Chief Operations Officer, Chief Executive Officer

Operations Manager

HIGHLIGHTS OF QUALIFICATIONS Synergistic Solutions * SIX SIGMA Certification * Lean Management Initiatives * Process Analysis Proven Leadership Skills * Regulatory Compliance * Budgetary Oversight * Relationship Builder Strong Team Builder * Customer Service First * Successful Business Owner * On-Time Service Operations Excellence * Inventory/Shrink Controls * Expense Reduction * Profit Enhancement Effective, Creative Commu...

Tags for this Online Resume: Management, Project Management, Supply Chain, Packaging, Process Improvement, Quality, Quality Assurance, Quality Control, Logistics, Manufacturing

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

Facilities Manager

Summary Experienced Facilities and Maintenance Manager focused on increasing organizational efficiency and productivity by guaranteeing that facilities and equipment are kept in optimal running condition. ACCOMPLISHMENTS Managed and maintained 4 facilities in the Athens area Oversaw construction completion and ontime opening of 3 new facilities Oversaw ontime closure and decommissioning of 2 old facilities Negotiated PM con...

Tags for this Online Resume: Accounts Receivable, Blue Prints, Blueprints, HVAC, Distribution, Documentation, Instrumentation, Manufacturing, Schematics, Training