Quality Systems Specialist II

Who we are?

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible.

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible.

As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.

Reporting to the Quality Systems Manager
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The Quality Systems Specialist supports the maintenance and continuous improvement of the site Quality Management System (QMS). The role leads and supports investigations, CAPAs, quality metrics, Annual Product Reviews (APRs), management reviews, inspection readiness, and other quality initiatives to ensure compliance with FDA, customer, and company requirements.

Working cross-functionally, the specialist helps resolve deviations, identify recurring trends, implement sustainable improvements, and maintain accurate documentation and communication with internal and external stakeholders.

Success in this role requires strong analytical, organizational, and communication skills, along with experience in quality systems, investigations, and continuous improvement within a regulated manufacturing environment.

Support and provide final review and approval of quality system investigations (deviations) not associated with specific product batches, ensuring investigations are comprehensive, well-documented, and supported by appropriate assessments and conclusions.

Coordinate with subject matter experts and cross-functional teams to ensure investigations are completed accurately and within established timelines.

Manage CAPAs associated with deviations, customer complaints, and audit observations using Track Wise.

Partner with functional departments to identify, implement, and monitor corrective and preventive actions (CAPAs) that address root causes and promote continuous quality improvement.

Coordinate completion of investigation documentation and prepare concise summaries communicating findings and conclusions. Provides completed deviation documentation to customers, as required.

Support regulatory inspections, customer audits, and internal audits to ensure inspection readiness and compliance.

Provide Back Room support during audits.

Document inspection activities and outcomes in Track Wise in accordance with required timelines.

Track and ensure timely completion of CAPAs following audits and inspections.

Monitor, compile, and report key quality performance indicators (KPIs) on weekly, monthly, and quarterly schedules.

Prepare KPI reports for Site Leadership, including metrics related to deviations, CAPAs, Right First Time (RFT), change controls, recurrence trends, and other quality system indicators.

Develop and present quality metrics and supporting data for Quality Performance Review meetings.

Perform monthly trend analysis of deviations and customer complaints to identify recurring issues and opportunities for process improvement through implementation of corrective actions.

Present recurrence trends and improvement recommendations during Quarterly Quality Review meetings.

Author Annual Product Review reports in accordance with customer requirements and established timelines.

Collect, validate, and analyze product quality data, including statistical evaluations where applicable, to identify trends and improvement opportunities.

Coordinate the review, approval, and customer feedback process for APR reports, ensuring timely resolution of comments and final approval.

Propose and implement process improvements to enhance the Annual Product Review Process.

Lead or participate in site continuous improvement projects and cross-functional working groups.

Implement process improvements through document revisions, batch record updates, forms, and related quality system enhancements.

Ensure compliance with regulatory, customer, and internal quality requirements across all assigned initiatives.

Complete assigned projects and action items within established timelines while supporting a culture of operational excellence.

Bachelor's degree in Chemistry, Biology, Pharmaceutical Science, Health Sciences, or related scientific discipline preferred. Equivalent combination of education and relevant Quality Assurance experience may be considered.

Minimum of three years of Quality Assurance experience in an FDA-regulated manufacturing environment.

Experience supporting…