Product Quality Specialist

Product Quality Specialist

The Product Quality Specialist role within the Regulatory and Quality Compliance (RQC) department will work to ensure that TraceLink’s Life Sciences Cloud, other SaaS systems, and service offerings comply with applicable global regulations and standards (i.e., 21 CFR 11, EU Annex 11, ISO 9001, ISO 27001, 21 CFR 820/211, FDA guidance documents, GAMP5) and customer requirements. This position serves as embedded independent oversight within the Software Development Lifecycle (SDLC) process.

Responsibilities:

• Review product requirements, design, and test plan documents in a timely manner per the SDLC.
• Review defined software release criteria and approve new software versions for release to customers.
• Primary RQC representative to participate in software deployments to customer environments as scheduled (includes night and weekend deployments).
• Verify Installation Qualification (IQ) for deployments following TraceLink procedures.
• Create, review, and approve IQ and Operational Qualification (OQ) Certificates for customers.
• Support risk management activities and improvements related to the SDLC.
• Serve as RQC department representative at various SDLC related meetings.
• Support the CAPA program for SDLC-related issues, including performing root cause analysis (RCA), and working with departmental representatives to determine and track corrective and preventive actions to completion in a timely manner.
• Author RCA summary reports for customer distribution for applicable CAPAs.
• Perform and document internal tool qualification activities, and work with other departments to evaluate internal tools for qualification, based on TraceLink procedures.
• Review and approve monthly validation documents for TraceLink’s PQ service offering.

General:

• Ensure organizational compliance with applicable global regulations and standards, TraceLink QMS processes, and customer
• Ensure quality for SaaS systems and service offerings is maintained.
• Identify and propose process improvements, efficiencies, or changes related to the SDLC or RQC’s supporting activities.
• Support customer audits or requests for information.
• Support internal audits and vendor
• Contribute to quality metrics and key performance indicator reporting, Quality Plan objectives, and team initiatives.

Required:

• BS in engineering, computer science, information systems, or other scientific discipline.
• 2-4 years performing SDLC, validation, verification, and/or qualification activities within the pharmaceutical, life sciences, medical device, or other related industry.
• Demonstrated knowledge of global regulations and standards related to software development, validation, and risk management for the Pharmaceutical, Medical Device, or Life Sciences industry (e.g., 21 CFR 11, EU Annex 11, ISO 9001, ISO 27001, 21 CFR 820/211, GAMP5, ICH Q9, Q10) .

Preferred:

• Familiarity with cloud-based software systems qualification, development, requirements authoring, or automated testing. Familiarity with Amazon Web Services (AWS) IaaS.
• Computer System Validation (CSV) experience with the understanding of the following Standard Operating Procedures, customer audit expectations, IQ, OQ & PQ documentation, review and approval process.
• Vendor audit or Internal Audit experience.