Quality Assurance Officers

Quality Systems Specialist II
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. Reporting to the Quality Systems Manager,

The QualitySystems Specialist supports the maintenance and continuous improvement of thesite Quality Management System (QMS). The role leads and supportsinvestigations, CAPAs, quality metrics, Annual Product Reviews (APRs),management reviews, inspection readiness, and other quality initiatives toensure compliance with FDA, customer, and company requirements.

Workingcross-functionally, the specialist helps resolve deviations, identify recurringtrends, implement sustainable improvements, and maintain accurate documentationand communication with internal and external stakeholders.

Success in thisrole requires strong analytical, organizational, and communication skills,along with experience in quality systems, investigations, and continuousimprovement 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.

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) that address root causes and promote continuous quality improvement.

Provides completed deviation documentation to customers, as required.

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

Document inspection activities and outcomes in TrackWise in accordance with required timelines.

Quality Performance Metrics
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.

Trend Analysis and Continuous Improvement
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 itemswithin 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 internal, customer, or regulatory audits and inspections is preferred.

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.

COMPUTER SKILLS

Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.

Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.

Must be able to work on a computer for extended periods of time.

Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

100% employer-paid medical premiums(a $2,000-$6,000+ annual value)

Annual performance bonuses and merit increase eligibility

At Unither, we don’t just offer competitive hourly wages-we also pay 100% of your medical premiums. 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.

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 propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.

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