Specialist Quality Assurance

Base pay range

$30.00/hr - $32.00/hr

This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification at ANC with a focus on Computer System Validation and Automation support. The individual will work with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight 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 the site, including facilities/utilities, equipment/systems, computerized systems, and process and validation maintenance, with an emphasis on Computer Systems Validation (CSV).
• Serve as the QAraft partner on a varied portfolio of DTI and automation platform projects, providing portfolio planning, resources, risk management, and QA oversight.
• Support DTI in cross‑system analysis, feasibility analysis, scope definition, prioritization of deliverables, and joint recommendation of optimal solutions.
• Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
• Provide QA support for management of DTI platform activities, including system administration, troubleshooting, vendor management, platform lifecycle, and business requirements.
• Review and approve qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV for computer systems validation.
• Provide guidance and support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies as required.
• Ensure all activities and 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 compliance concerns or critical gaps to QA management.
• In line with business requirements, these responsibilities may expand to additional areas not described in this specification but that are associated with the role.

• Previous experience in computer system validation (CSV) or quality oversight of CSV.
• Experience with Data Historian (OSI PI), MES (Korber), Delta V Automation platform, laboratory systems, and/or IS platforms is highly desired.
• Experience with computerized systems, including troubleshooting, reliability, and performance improvements.

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, including medical, dental, vision, health savings accounts, paid days off, 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.

Entry level

Contract

Quality Assurance