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Online Resumes with "regulated environment"



Operations Manager

COVER LETTER: Dear Sir / Dear Madam: As an adept and knowledgeable manufacturing manager with over 20 years of experience ensuring the cost-effective operations of high-capacity production facilities in the medical device and biopharmaceutical industries, I am writing to express my interest in the [Production Manager] role with your company. Offering a history of success reducing costs, increasing capacity, and boosting emp...

Tags for this Online Resume: Medical, Medical Devices, Management, Inventory, Inventory management, Scheduling, Research, Research and Development, Audit, Cost Control

Business Analyst

Qualifications Summary * Over Twenty years' technical writing experience in an enterprise delivery setting. Expertise with end-to-end SDLC/ITIL software development process industries I've worked in include: Electric Utilities, Financial Services, Mining, Food and Beverage, Food and Produce Distribution, Health Imaging, Manufacturing, Oil and Gas, Pharmaceutical IT, Retail and Media Relations * Develop both classroom and we...

Tags for this Online Resume: Documentation, Lightweight Directory Access Protocol, Research, Research and Development, Risk Analysis, Script, Technical Documentation, Test, Test Script, Technical Writing

Convention Services/Events Staff - 20 Years of Experience - Near 33308

SUMMARY A robust background and dutiful respect for compliance in regulated environments. Results oriented and hands-on proficiencies in sales, customer relationship management, program development, quality assurance, and training within broad-minded companies. Maintains strong focus on providing clients with the highest quality of service and integrity. Strengths include leadership, competency, solid team player, and atten...

Tags for this Online Resume: Sales, Business Development, Customer Relationship Management, Management, Packaging, Audit, Compliance, Consumer Lending, Loan Portfolios, Security

Programmer

* Held DoD Secret Clearance as well as DHS secret clearance and Trusted Persons Clearance State of Georgia. Worked Systems Software Group. This area worked with the Fixed Wing Helicopter areas, delivering software interfaces for data management and tracking. Used Coldfusion, extJS, JavaScript, CFScripting, JQuery, Query of Queries, CSS3, HTML4, SQL Server, Oracle Database. MVC Framework. Part of the CMMI compliance work gro...

Tags for this Online Resume: Active Server Pages, BASIC Programming Language, Javascript, Visual Basic, Intranet, Java Programming Language, Macromedia ColdFusion, Management, SQL 2000, Structured Query Language

Scientist - 15 Years of Experience - Near 10954

SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...

Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, C Programming Language, Filing

Principal Engineer

ACCOMPLISHMENTS * Project management of Medical Device right from conceptualisation to manufacture in an ISO/FDA regulated environment. Used suitable stage gates and milestone list to inform key stakeholders about progress of the project. * Planned the project budget, schedule and used change control procedures for controlling changes and preventing scope creep. Negotiated with functional managers for resource allocation an...

Tags for this Online Resume: Medical, Medical Devices, Engineering, Instrumentation, ISO, Management, Cancer, Documentation, Manufacturing, NPI

Department Manager

PROFESSIONAL SUMMARY Dynamic Environmental, Health, Safety and Quality professional with twenty years of experience in the pharmaceutical industry (oral solid dosage and active pharmaceutical ingredient). Strong knowledge in Project Management, Manufacturing, Operations, Equipment Qualification and Process Validation. Expertise in regulated environments: cGMP compliance, OSHA, EPA, PSM and FDA. Teamwork oriented and Leaders...

Tags for this Online Resume: Project Management, Compliance, FDA, cGMP, Process Engineer, Sr. Safety Engineer, PSM, Training, OSHA, CQA

Manager - 20 Years of Experience - Near 47401

Summary Deep listener. Optimist. Mentor. Preferred contact method: email annabeauchamp39@gmail.com. Strong leadership capabilities, including the ability to lead high performing teams, think strategically and with excellent negotiation and influencing skills. Demonstrable knowledge of international GMP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment.

Tags for this Online Resume: Manufacturing, Integrate, Media Relations, Publications, Social Media, Management, Leadership, Root Cause Analysis, Complaints, Enterprise Software

Mechanical Engineer

Summary: * Results-driven Manufacturing & Product Engineering Professional with a strong background in process development and validation, technology, product transfers, fixture design, development, and validation within highly regulated medical device environments including optical, opto-mechanical, and electro-mechanical systems and devices. * 10+ Years' Experience in writing validation/verification protocols and reports,...

Tags for this Online Resume: Manufacturing, Documentation, Purchasing, Test, Critical Care - Vascular, ISO, ISO 9000, LAPAROSCOPY, Product Development, Urology

Laboratory Technician - 13 Years of Experience - Near 08510

SUMMARY OF QUALIFICATIONS: Expertise working in a regulated environment following Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) and Standard Operating Procedures (SOPs) in both analytical and animal toxicology laboratories. Maintains and oversees sample management operations including the Rees environmental monitoring system, Watson sample acquisition information and tracking of GLP Bioanalytical & Immuno...

Tags for this Online Resume: Audit, Documentation, Monitoring, Process Improvements, Quality, Quality Assurance, Quality Control, Test, Transportation, Customer Service

Quality Engineer

SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.

Tags for this Online Resume: Packaging, Manufacturing, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Quality Control, Training

Featured Profile

Department Manager - 20 Years of Experience - Near 92058

Results-driven engineering, plant management professional with broad-based experience planning and leading plant operations within large-scale cosmetic manufacturing and packaging in FDA regulated environments. Solid track-record devising, evaluating, and implementing continuous process improvements minimizing waste and reducing costs while maximizing quality and yield. Establish effective quality control and safety program...

Tags for this Online Resume: Maintenance/plant management, Install, Lean Manufacturing, Manufacturing, Packaging, Policies and Procedures, Cms, Defense, Kaizen, Light Emitting Diode