Overview
Quality Technician – Days – Wed-Sat 12 hrs. Jobs in Darien, WI at Power Solutions International (PSI)
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you’ll love working at Axogen:
Friendly, open, and fun team culture that values unique perspectives
Company-wide dedication to profoundly impacting patients’ lives
Comprehensive, high-quality benefits package effective on date of hire
Educational assistance available for all employees
Matching 401(k) retirement plan
Paid holidays, including floating holidays, to be used at your discretion
Employee Stock Purchase Plan
Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Computer System Validation Analyst
The Computer System Validation Analyst will demonstrate strong expertise in Computer System Validation (CSV), business analysis, and light-touch project management. This hybrid role will lead validation and compliance efforts for IT systems with GxP impact while acting as the bridge between business units, QA, and IT teams to drive successful project execution. This position reports to the Sr. Director, Enterprise Architecture, Data Analytics, & AI and will partner closely with IT, QA, and various business units (e.g., R&D, Clinical, Operations, and Finance). Occasional travel to other Axogen sites (Dayton, OH; Burleson, TX; and Alachua, FL) may be required.
Requirements of the Computer System Validation Analyst
Bachelor’s Degree in Biomedical Engineering, Information Technology, Pharmaceutical Sciences, or related field, along with 5 years of experience in the Software Industry, specializing in GxP and validated systems or 10 years of professional experience in an IT Business Analyst role, specializing in GxP and validated systems, without a formal degree.
In-depth knowledge of GAMP 5 and 21 CFR Part 11 principles.
Strong track record in authoring, executing, and approving validation documentation across the full SDLC.
Experience in business analysis: eliciting requirements, process modeling, and traceability management.
Strong understanding of QMS systems and document routing/tracking in a compliance-driven environment.
Experience managing change controls and periodic review processes.
Exposure to Agile or hybrid project methodologies with the ability to manage multiple concurrent initiatives.
Strong verbal and written communication skills — able to engage technical and non-technical audiences.
Familiarity with ERP, LIMS, MES, ELN, and SaaS-based GxP systems.
Formal training or certification in Computer System Validation (CSV), such as courses offered by ISPE, NSF, CfPIE, or equivalent recognized organizations.
Knowledge of MasterControl or other E-QMS platforms.
Responsibilities of the Computer System Validation Analyst
The specific duties of the Computer System Validation Analyst include but are not limited to:
Develop and execute risk-based validation strategies aligned with GAMP 5, 21 CFR Part 11, and data integrity standards.
Author, review, and approve validation deliverables: URS, FRS, Risk Assessments, IQ/OQ/PQ Protocols, Summary Reports, Traceability Matrices, and Data Integrity Checklists.
Lead validation efforts for new and upgraded GxP systems, including but not limited to SaaS, ERP, EBR, LIMS, MES, and QMS platforms.
Enhance and align the existing CSV program in collaboration with Quality partners, ensuring it supports compliance while reducing the burden of maintaining validated IT systems at Axogen.
Support internal and external audits related to computerized systems and data integrity compliance.
Elicit, document, and manage business and user requirements through workshops, interviews, and process mapping.
Translate requirements into functional specifications, traceability matrices, and change controls.
Serve as a trusted liaison between business stakeholders, QA, technical teams, and external vendors to drive project milestones while ensuring seamless communication and compliance.
Route and track validation documents and project deliverables in the QMS for review and approval.
Create and manage change controls in the QMS for system updates or improvements and proactively drive them forward through the full approval lifecycle.
Collaborate with Quality and Business Owners to conduct periodic system reviews to ensure continued compliance, identify gaps, and initiate remediation efforts if necessary.
Ensure that document updates, system revisions, and process changes are appropriately documented and maintained according to regulatory expectations.
Build and manage project charters, high-level timelines, RACI charts, and resource plans for small-to-mid-sized initiatives.
Lead stand-ups, track risks/actions/issues/decisions (RAID), and escalate blockers to ensure on-time, in-scope, on-budget delivery.
Ensure vendor deliverables meet Axogen’s internal quality and regulatory standards.
Generate and present project status reports to leadership and regulatory stakeholders.
Identify process gaps, propose improvements, and advocate for continuous enhancement of validation and compliance practices.
Location
111 West Oak Ave., Tampa, FL 33602
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Benefits/Compensation
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
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Title: Quality Technician – Days – Wed-Sat 12 hrs.
Company: Power Solutions International (PSI)
Location: Darien, WI
