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About the Role

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

Responsibilities

Support and provide final review and approval of quality system investigations (deviations) not associated with specific product batches.
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 TrackWise.
Partner with functional departments to identify, implement, and monitor corrective and preventive actions (CAPAs).
Coordinate completion of investigation documentation and prepare concise summaries communicating findings and conclusions.
Provide 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 TrackWise 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, 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.
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.
Coordinate the review, approval, and customer feedback process for APR reports.
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.

Requirements

Minimum of three years of Quality Assurance experience in an FDA-regulated manufacturing environment.
Experience supporting internal, customer, or regulatory audits and inspections is preferred.

Skills

Self-motivated with the ability to quickly learn new processes and effectively manage multiple priorities in a fast-paced environment.
Demonstrated ability to work independently while following established procedures and seeking guidance when appropriate.
Good teamwork skills.
Excellent communication, interpersonal and organization skills.
Demonstrates sound problem-solving skills by promoting innovative, compliant solutions and ensuring effective implementation of corrective actions.
Ability to recognize situations where there is a potential impact on product quality, safety, identity and purity.
Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
ERP, TrackWise, EnnovDoc familiarity preferred.

Location

Rochester, NY

Work Type

Onsite
Full-time

Experience Level

3+ years

Education Level

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.

Salary/Compensations

80,000.00 - 90,000.00 USD

Benefits

100% employer-paid medical premiums
401(k) contributions: 6% match plus an additional 4% company-funded contribution
HSA contributions with wellness incentives
Annual performance bonuses and merit increase eligibility

About the Company

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.
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!

Equal Opportunity

Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.