Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $30.00 – $32.00/hr.
Summary:
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.
Responsibilities:
- 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 cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solutions.
- 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.
- 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.
Must Have Skill:
- Previous experience in computer system validation (CSV) or quality oversite of CSV.
- Experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms, highly desired.
- Experience with computerized systems including troubleshooting, reliability, and performance improvements.
Pay Transparency: The typical base pay for this role across the U.S. is: $30.00 – $32.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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