Overview:

The Product Quality Specialist role within the Regulatory and Quality Compliance (RQC)

department will work to ensure that TraceLink’s life sciences applications and service offerings

comply with applicable global regulations and standards (i.e., ISO 9001, FDA 21 CFR Part 11,

EU Annex 11, FDA guidance documents, GAMP5) and customer requirements. This position

serves as embedded independent oversight within the Software Development Lifecycle (SDLC)

process.

Responsibilities:

• Review product test plan documents as per the requirements, design 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 assurance activities and work with other
• departments to evaluate tools based on TraceLink procedures.
• Review and approve validation documents for TraceLink’s automated validation service
• offering.

General:

• Ensure organizational compliance with applicable global regulations and standards,
• TraceLink QMS processes, and customer requirements
• Ensure quality for SaaS products 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.
• Support ISO 9001 and 27001 audits.
• Contribute to quality metrics and key performance indicator reporting, quality objectives,
• and team initiatives.

Qualifications:

Required:

• BS in engineering, computer science, information systems, or other scientific discipline.
• 2-4 years performing software validation, assurance, 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., US FDA 21 CFR 11, EU Annex 11, ISO 9001, ISO 27001,
• FDA Computer Software Assurance [CSA], US FDA 21 CFR 820/211, GAMP5, ICH Q9,
• Q10).
• Ability to work independently and as a team member in fast-paced environment, in an
• effective and flexible manner.
• Strong interpersonal skills to be able to build trust and relationships with cross-functional
• teams, challenge constructively, and collaborate and deliver results as a team.
• Strong written and verbal communication skills.

Preferred:

• Familiarity with cloud-based software qualification, development, requirements
• authoring, or automated testing.
• Familiarity with Amazon Web Services (AWS) IaaS.
• Computer System Validation (CSV) and/or Computer Software Assurance (CSA)
• experience with the understanding of following Standard Operating Procedures,
• independent reviews, and documentation requirements.
• Vendor audit or Internal Audit experience.