Sr. QA Specialist – NC/CAPA Training & Quality Systems

Required Skills & Experience

Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or related field preferred.

5+ years of pharmaceutical, biotech, medical device, or similarly regulated Quality experience.

Hands-on experience with Nonconformance/deviations, CAPA, investigations, root cause analysis, record/documentation quality, and cGMP/Good Documentation Practices.

Experience delivering training, facilitating workshops, supporting competency programs, or communicating Quality requirements to stakeholders.

Experience working with quality metrics, KPIs, reporting, dashboards, or data analysis.

Experience with NC/CAPA harmonization or standardization initiatives.

Experience assessing investigation quality or CAPA effectiveness.

Strong communication and presentation skills.

Ability to confidently interact with experienced site stakeholders and appropriately challenge resistance while remaining collaborative.

Ability to work independently across a global, matrixed organization.

Nice to Have Skills & Experience

Power BI experience.

Power Apps experience.

ThoughtSpot experience.

Experience supporting global or multi-site Quality organizations.

Knowledge of U.S. and international pharmaceutical GMP requirements.

Job Description

We are seeking a Quality Systems Specialist to support a global pharmaceutical supply chain organization focused on Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes. This individual will support an enterprise-wide NC/CAPA training and competency initiative, helping deploy training and assessments, track employee competency and completion, monitor process performance, and provide metrics and reporting across the organization.

The ideal candidate has a strong foundation in NC/CAPA, investigations, root cause analysis, and GMP quality systems, combined with strong communication skills and experience supporting training, metrics, dashboards, or quality-system reporting.

This is not primarily a day-to-day CAPA investigator position. The individual needs enough NC/CAPA expertise to understand what good investigations and documentation should look like and confidently communicate those expectations to experienced stakeholders.

Key Responsibilities

Support deployment of NC/CAPA training, competency assessments, and certification activities across a global pharmaceutical supply chain organization.

Help manage assessment results, identify upskilling requirements, monitor training completion, and track competency progress.

Facilitate NC/CAPA training, workshops, and case-study-based learning for site-level Quality stakeholders.

Use knowledge of investigations and CAPA to help communicate expectations around investigation quality, root cause analysis, documentation, corrective actions, and process compliance.

Support review and monitoring of NC/CAPA records to assess process health, quality, and compliance.

Develop and maintain metrics, KPIs, dashboards, and reporting related to NC/CAPA performance and training/competency.

Extract and analyze data used to provide visibility into program performance.

Support existing Power Apps from a business/user perspective, including end-user support, administration, data extraction, reporting, and gathering user feedback.

Partner with technical/development teams on Power App enhancements and reporting needs.

Utilize or learn reporting tools such as Power BI and ThoughtSpot.

Partner with site Business Process Owners, Quality leadership, and global stakeholders to drive adoption of standardized NC/CAPA expectations.

Identify and communicate compliance risks or process concerns to Quality Systems leadership.

Support multiple priorities in a highly matrixed, global organization.