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Senior Logistics Specialist
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Chief Information Security Officer (CISO)
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Head Universal Banker - Merrifield Branch
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Credentialing & Privileging Manager
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Software/IT Engineering Manager
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Senior Product Operations Manager
Weave
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- 8+ years of experience in Product Operations, Technical Program Management ,Product Management, Engineering, or a related discipline within a SaaS or technology company.
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GA
Sr Manufacturing Engineer - Sourced Hardware
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Charlottesville, VA · Glen Allen, VA
- $136,000 to $181,000 USD / year
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Digital Technical Product Manager Senior - Digital Claims
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Head Universal Banker - Reston Branch
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Champion risk and control by monitoring day-to-day operations, ensuring compliance with policies, supporting the Branch Manager
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Global Environmental Construction Program Lead, AWS Environmental
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Senior Technical Program Manager, Electrical Products and Services, Data Center Engineering
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The Sr. Technical Program Manager drives the at-scale global implementation of the newest generations of data center electrical products and electrical distribution infrastructure…
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Global H&S Audit Manager, AWS Health & Safety
Amazon
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Principal Payment Tech Development Manager
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The Principal Payment Tech Development Manager will lead the end-to-end design, development, testing, certification, and delivery of contact/contactless chip technologies, mobile payments,…
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Investments and Business Case, Principal
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MITRE is seeking an Investments and Business Case Manager within the Finance sector to develop investment theses and build repeatable, high-quality business cases for enterprise and…
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Application Integration Engineer
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…modernization effort. This role will support the Solution Architect and senior technical leads by developing Java/Spring Boot RESTful APIs, configuring AWS cloud-based integration…
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Senior Engagement Manager, AWS ProServe EDU & SLG
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Possessing strong technology and program/project management experience, you will validate technical solutions against business goals, recognize when additional technical evaluation is…
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Software Development Manager, Benefits Experience & Technology (BXT)
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…team culture encourages innovation and we expect engineers and management alike to take a high level of ownership for the product vision, technical architecture and project delivery. We…
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Senior Program, Manager, Central Selection (Tools), WWGS (Worldwide Grocery Stores)
Amazon
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5+ years of program or project management experience
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Security Intelligence Analyst, Assessments, Risk Guidance and Outcomes (ARGO)
Amazon
Arlington, VA
This role is non-technical, but in order to be effective you’ll need to pursue, acquire, and grow foundational cloud and related AWS technical and business knowledge. Though this is an in…
Added 2 mins ago
Senior Technical Program Manager, Network Engineering
Amazon
Herndon, VA · Arlington, VA
Network Engineering is seeking a Technical Program Manager (TPM) to help us continue to build the largest network in the world. This role offers endless opportunities to work on latest…
Added 2 mins ago
Manager, Safety Policy Expert: Chemical and Environmental, Regulatory Intelligence, Safety, and Compliance Program
Amazon
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Amazon is seeking a Senior Policy Manager for Chemical & Environmental Compliance to lead the development and execution of product compliance policies across a complex and rapidly evolving…

Validation & Engineering Group

Sr Quality Assurance (Validation) Engineer - FL, USA

Deerfield Beach, FL, United States

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Job details

Experience: · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance.
Posting language: English
Posted: Apr 16, 2021

Original job description

Company Description Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

Reporting to the Senior Quality Assurance Manager, this position is responsible for Quality oversight of the local validation program which includes Facilities, Utilities, Manufacturing equipment and Computer Systems. The Engineer will contribute improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of Operations, Process Development, and IT. The engineer will approve validation, change control, investigation of events as well as provide Quality oversight and/or Quality approvals for GxP systems. The CSQA Engineer will provide oversight of SHL Pharma GxP related applications, and established Quality Operating procedures. In addition; will maintain a list of all computerized systems that are used in support of manufacturing operations, assure 21 CFR Part 11 pre- and post-assessments are performed on all systems and that computerized systems are released to production in accordance with local and global policies and procedures. The CSQA Engineer will review and approve validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts and discrepancies. In addition, will provide guidance to project teams on the deliverables required as part of the validation package. Assure that computerized systems are in the requalification program and are part of the program for security access roster review. · To Implement and maintain global and local procedures for computerized systems validation. · To drive standardization and continuous improvement activities across the global and local quality network · To provide QA oversight, review and approval of the activities related to the design, test, implementation, and maintenance of supported GxP systems.

· To help plan audit program and execute audits of:

Suppliers of computerized systems, components, and services
Computerized systems, projects and processes related to Computerized system.
Computerized systems at SHL’s partners (e.g. CMO Customers}, upon request · To monitor Quality Metrics and communicate to management to drive continuous improvement of regulated computerized systems and GXP relevant infrastructure. · To Identify and communicate risk in area of responsibility and across the quality network; creating strategies and plans to manage the risk. · To ensure deviations from established procedures are documented per procedures. · To ensure that all changes that potentially impact product quality are documented per procedure. · To ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Advises site management regarding Quality Assurance issues

Qualifications

· Bachelor’s degree in Computer Science / Computer or Biomedical Engineering · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance. · Demonstrated knowledge of predicate rules such as GLP, GMP, GCP, GAMP 5 as they relate to computerized systems. · Must have a strong knowledge and application of the CFR’s and cGMP’s. · Comprehensive knowledge of FDA, EMA, JP, ISO and other regulations and experience in US and international regulatory agency inspections. · Knowledge of regulations and practices pertaining to pharmaceutical/medical devices products in your area of responsibility. · Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. · Excellent oral and written communication skills with strong technical writing experience required. · Experience in internal / external audits, identify findings, drive resolution and provide closure report. · Proficient skills in solving complex problems and ability to bring issues to resolution. · Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. · Must be able to successfully pass a pre-employment drug test and background check. Experience working globally with diverse teams and cultures

Additional Information All your information will be kept confidential according to EEO guidelines.

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