Quality System Specialist

Title: QMS and Reporting Specialist

Location: Cambridge, MA (Hybrid)

Contract: 6 months+

Job Descriptio

nPosition Overvie

• wThe 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 Responsibiliti

• esDeviation Training Program & Support Model Executi
• onSupport implementation of a deviation investigator training pilot program, incorporating adult learning principles and hands-on applicatio
• n.Develop training materials (case studies, templates, guidance tools) to improve investigation quality and consistenc
• y.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 scalabilit

y.
2. Quality Metrics, Scorecard & KPI Enhancem

• entSupport execution and delivery of Quality scorecards, dashboards, and KPI framewor
• ks.Perform data aggregation, trending, and root-cause-oriented analysis across deviations, CAPAs, and change contro
• ls.Support routine and ad hoc reporting requests for Quality Management Review and Quality Systems forums, ensuring data accuracy and consisten
• cy.Provide project management support across QMS initiatives (timelines, deliverables, stakeholder follow-up

s).
3. QMS Process Support & Technology Enable

• mentAssist with process mapping, gap assessments, and continuous improvement initiatives across QMS proces
• ses.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 accur

acy.
Qualificat

• ions:Bachelor’s degree in Life Sciences, Engineering, or related discip
• line.3-5 years of experience in GxP Quality Systems, QA operations, or QMS program sup
• port.Strong understanding of GMP, GLP, GCP regulations and ICH guide

lines
Demonstrated experience

• with:Quality Management System proc
• esses.Quality metrics, dashboards, and KPI develo
• pment.Data analysis and trending (Excel, Power BI, or equivalent t
• ools).Electronic quality management systems (Veeva strongly prefe
• rred).Preferred Qualifica
• tions.Bachelor's degree in related
• field.Experience with electronic Learning Management Systems and Document Management Sy
• stems.Experience with change management and organizational develo

pment.
Key Compe

• tenciesStrong process thinking and analytical
• skills.Strong experience in
• Excel.Excellence in project management and organi
• zation.Strong communication and facilitation
• skills.Ability to influence without direct authority and self-s
• tarter.Strong technical writing
• skills.Demonstrated ability to leverage AI-enabled tools while ensuring GxP compliance and data integrity prin