Quality System Specialist

Duration: 6 months

Manager Notes:

Day-to-Day Responsibilities

• Quality-related work with a strong emphasis on:
• Technical writing
• Meeting documentation and minutes
• Reporting activities
• Troubleshooting issues
• Working with quality systems
• Candidate should be comfortable adopting and leveraging new technologies, including AI tools.

Work Location

• Hybrid preferred (1-2x per week)

Experience Requirements

• Min. 3–5 years of experience.

Education Requirements

• Min Bachelor's degree or higher.
• Open to candidates with advanced degrees (Master's, PhD) but not required

Technical Skills / Tools

• Veeva Quality Systems.
• Microsoft Office Suite.
• Excel (pivot table experience preferred).

Job Description:

• The QMS and Reporting Support Contractor position within AIQ will serve as an enabler of multiple QMS initiatives, as well as support reporting and data analysis deliverables.
• This individual will report into the QMS and Reporting pillar of AIQ and partner with various GxP stakeholders who provide data input and deviation record ownership.

Key Responsibilities:

1. Deviation Training Program & Support Model Execution:

• Support implementation of a deviation investigator training pilot program, incorporating adult learning principles and hands-on application.
• Develop training materials (case studies, templates, guidance tools) to improve investigation quality and consistency.
• Partner with QA and deviation owners to establish a sustainable support model (office hours, coaching, knowledge resources).
• Analyze training program effectiveness metrics (e.g., quality of investigations, cycle times, rework trends) to inform program improvements and scalability.

2. Quality Metrics, Scorecard & KPI Enhancement:

• Support execution and delivery of Quality scorecards, dashboards, and KPI frameworks.
• Perform data aggregation, trending, and root-cause-oriented analysis across deviations, CAPAs, and change controls.
• Support routine and ad hoc reporting requests for Quality Management Review and Quality Systems forums, ensuring data accuracy and consistency.
• Provide project management support across QMS initiatives (timelines, deliverables, stakeholder follow-ups).

3. QMS Process Support & Technology Enablement:

• Assist with process mapping, gap assessments, and continuous improvement initiatives across QMS processes.
• Support data governance and data clean-up initiatives within the QMS.
• Leverage client-approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 3-5 years of experience in GxP Quality Systems, QA operations, or QMS program support.
• Strong understanding of GMP, GLP, GCP regulations and ICH guidelines

Demonstrated experience with:

• Quality Management System processes
• Quality metrics, dashboards, and KPI development
• Data analysis and trending (Excel, Power BI, or equivalent tools)
• Electronic quality management systems (Veeva strongly preferred)

Preferred Qualifications:

• Bachelor's degree in related field
• Experience with electronic Learning Management Systems and Document Management Systems
• Experience with change management and organizational development

Key Competencies:

• Strong process thinking and analytical skills
• Strong experience in Excel
• Excellence in project management and organization
• Strong communication and facilitation skills
• Ability to influence without direct authority and self-starter
• Strong technical writing skills
• Demonstrated ability to leverage AI-enabled tools while ensuring GxP compliance and data integrity principles