Gardner Resources Consulting, LLC | Sr Quality Engineer, Computerized Systems Quality
7 days ago
Sr Quality Engineer, Computerized Systems
Must Have:
- 7 years Computer Systems
- Validation
- Compliance – quality oversight
- GMP
- Proficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects
- Bachelor’s degree in IT or Computer Science
- 5+ years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
- Familiarization with ITIL/GAMP5 Validation Lifecycle
- 21 CFR, EU regulations
- Take Quality ownership, participate in cross functional team discussions, provide quality guidance/decisions for the projects that includes New implementation, Enhancements, Quarterly releases, etc.
- Participate and Drive System Assessments, review and approve the project deliverables including plan, test scripts, execution and its outcome, reports, traceability
-
Boston, United States Gardner Resources Consulting, LLC Full timeSr Quality Engineer, Computerized SystemsMust Have:7 years Computer SystemsValidationCompliance – quality oversightGMPProficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projectsBachelor’s degree in IT or Computer Science5+ years of proven experience in...
-
Boston, United States Gardner Resources Consulting, LLC Full timeSr Quality Engineer, Computerized SystemsMust Have:7 years Computer SystemsValidationCompliance – quality oversightGMPProficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projectsBachelor’s degree in IT or Computer Science5+ years of proven experience in...
-
boston, United States Gardner Resources Consulting, LLC Full timeLinux Engineer that will be responsible to act as Linux engineering subject matter expert on projects and business support requests of all sizes, from initiation through successful completion.Candidates should be able to provide multiple solution approaches and be able to perform the engineering and drive the development required to implement any selected...
-
boston, United States Gardner Resources Consulting, LLC Full timeSr Specialist, GDP Operational QAMust Have: · 5+ years’ experience serving in a Quality role.· Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.· Influencing skills in areas with no direct reporting authority.· Strong interpersonal and communication skills.· Auditing skills,...
-
boston, United States Gardner Resources Consulting, LLC Full timeSr Specialist, GDP Operational QAMust Have: · 5+ years’ experience serving in a Quality role.· Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.· Influencing skills in areas with no direct reporting authority.· Strong interpersonal and communication skills.· Auditing skills,...
-
boston, United States Gardner Resources Consulting, LLC Full timeInspection Readiness Manager Must Have: Master’s degree and 3 – 4 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 5+ years of relevant work experience, or relevant comparable backgroundProficient at creating tools and processes for efficient executionProficient in project management and utilization of...
-
boston, United States Gardner Resources Consulting, LLC Full timeDigital Medical Product Manager Must Have: Strong knowledge of digital project execution with some understanding of other medical affairs functions relevant to the position.Strong interpersonal skills with experience supporting cross-functional teams in matrix environment; skilled at exchanging complex/sensitive information and influencing others to take...
-
boston, United States Gardner Resources Consulting, LLC Full timeDigital Medical Product Manager Must Have: Strong knowledge of digital project execution with some understanding of other medical affairs functions relevant to the position.Strong interpersonal skills with experience supporting cross-functional teams in matrix environment; skilled at exchanging complex/sensitive information and influencing others to take...
-
Quality Systems Engineer
1 week ago
Boston, Massachusetts, United States Connexion Systems & Engineering, Inc. Full timeQuality Systems EngineerWe are seeking a talented Quality Systems Engineer to join our team at Connexion Systems & Engineering, Inc. in Boston.The successful candidate will be responsible for promoting MTO and QA-aligned compliance best practices to further establish operational and quality event record center of excellence teams.This is a full-time position...
-
Sr Manager GCP Compliance
2 months ago
Boston, United States Gardner Resources Consulting, LLC Full timeSr Manager, GCP ComplianceMUST HAVE: Experience successfully leading event investigations, Root Cause Analysis and CAPAKnowledge of current industry trends and ability to use the latest technologiesHighly organized with strong planning capabilitiesCompliance and quality management experience (across multiple GxP areas) preferredStrong communication, problem...
-
Sr Manager GCP Compliance
2 months ago
Boston, United States Gardner Resources Consulting, LLC Full timeSr Manager, GCP ComplianceMUST HAVE: Experience successfully leading event investigations, Root Cause Analysis and CAPAKnowledge of current industry trends and ability to use the latest technologiesHighly organized with strong planning capabilitiesCompliance and quality management experience (across multiple GxP areas) preferredStrong communication, problem...
-
Sr Manager GCP Compliance
2 months ago
boston, United States Gardner Resources Consulting, LLC Full timeSr Manager, GCP ComplianceMUST HAVE: Experience successfully leading event investigations, Root Cause Analysis and CAPAKnowledge of current industry trends and ability to use the latest technologiesHighly organized with strong planning capabilitiesCompliance and quality management experience (across multiple GxP areas) preferredStrong communication, problem...
-
Sr. Validation Engineer
4 weeks ago
Boston, United States Barry-wehmiller Companies Inc. Full timeAbout Us: Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the worlds leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry...
-
Quality Assurance Sr. Specialist
1 month ago
Boston, United States Katalyst Healthcares and Life Sciences Full timeDescription:seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA. The individual in this role will be part of a cohesive team responsible for supporting...
-
Linux Engineer
2 months ago
Boston, United States Gardner Resources Consulting Full timeOur insurance client is seeking a Linux Engineer that will beresponsible to act as Linux engineering subject matter expert on projects and business support requests of all sizes, from initiation through successful completion. •Candidatesshould be able to provide multiple solution approaches and be able to perform the engineering and drive the development...
-
Linux Engineer
5 days ago
Boston, United States Gardner Resources Consulting, LLC Full timeLinux Engineer that will be responsible to act as Linux engineering subject matter expert on projects and business support requests of all sizes, from initiation through successful completion.Candidates should be able to provide multiple solution approaches and be able to perform the engineering and drive the development required to implement any selected...
-
Linux Engineer
6 days ago
Boston, United States Gardner Resources Consulting, LLC Full timeLinux Engineer that will be responsible to act as Linux engineering subject matter expert on projects and business support requests of all sizes, from initiation through successful completion.Candidates should be able to provide multiple solution approaches and be able to perform the engineering and drive the development required to implement any selected...
-
Data Engineering Manager
3 weeks ago
Boston, United States Gardner Resources Consulting Full timeOverview: We are seeking an experienced and dynamic Data Engineering Manager to lead our data engineering team in building and maintaining robust, scalable data solutions. This role involves a mix of technical expertise and leadership skills to manage a team while driving data strategies and ensuring alignment with business goals. Key Responsibilities:...
-
Sr. Network Engineer
6 days ago
Boston, United States Spyglass Partners LLC Full timePosition Type: Contract/Contract to Hire Hourly:$40-60/hr Our client in the Manufacturing Industry is looking to add a Sr. Network Engineer to their team. The responsibilities of this position are to assist with the growth of the organization and strengthen the network infrastructure for the team. Requirements: 5+ Years of experience in Network...
-
Sr. Process Engineer
1 month ago
Boston, United States Barry-Wehmiller Companies Inc Full timeAbout Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine...