Specialist Quality Assurance
Holly Springs, NC, US • Posted 1 day ago • Updated 15 hours agoFull Time
On-site


ApTask Global Workforce
Fitment
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Job Details
Skills
- FOCUS
- Innovation
- Risk Management
- Systems Analysis
- Feasibility Study
- Management
- System Administration
- Vendor Management
- Risk Assessment
- Computerized System Validation
- Application Lifecycle Management
- Test Scripts
- ServiceNow
- Quality Assurance
- Maximo
- Leadership
- Testing
- Manufacturing
- Documentation
- Collaboration
- Issue Resolution
- Regulatory Compliance
- QA Management
Summary
100% Onsite | Holly Springs NC (USNC)
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification at ANC with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem at ANC and ongoing Automation support to the Manufacturing floor and expansion projects.
Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV).
Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight.
Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution.
Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation.
o May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders.
Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and *** requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
Participate in meetings related to document planning, execution, and issue resolution.
Escalate any compliance concerns or critical gaps to QA management.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification at ANC with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem at ANC and ongoing Automation support to the Manufacturing floor and expansion projects.
Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV).
Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight.
Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution.
Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation.
o May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders.
Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and *** requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
Participate in meetings related to document planning, execution, and issue resolution.
Escalate any compliance concerns or critical gaps to QA management.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 10103941a
- Position Id: 26-00698
- Posted 1 day ago
Company Info
About ApTask Global Workforce
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions provider supporting clients in healthcare, life sciences, technology, and professional operations. AGW delivers clinical, lab, operational and administrative talent through programs that emphasize dependability, strong communication and steady performance. The company offers experience in regulated environments and maintains a commitment to consistent delivery supported by established processes and dedicated leadership. AGW operates independently and continues to serve clients with the same structure, programs and certifications that define its work today.
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