Quality Systems Specialist II

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 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.

Your role

Reporting to the Quality Systems Manager,

JOB SUMMARY

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.

DUTIES / RESPONSIBILITIES

Deviations and CAPA

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 TrackWise.

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.

Internal and External Audits

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.

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.

Annual Product Review Reports

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.

Continuous Improvement and Compliance

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.

Your profile

REQUIRED EDUCATION

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.

QUALIFICATIONS/EXPERIENCE

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.

SPECIFIC 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.

COMPUTER SKILLS

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

ERP, TrackWise, EnnovDoc familiarity preferred.

F. PHYSICAL REQUIREMENTS/ENVIRONMENT:

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.

Must wear PPE as required.

Sitting 75% of the day; standing or walking 25%.

Frequently subjected to pressure due to time-sensitive demands.

Compensation range

80,000.00 - 90,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. 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.

A Smarter Total Compensation Package

At Unither, your base salary is just the beginning. Our Total Rewards include:

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

• 401(k) contributions: 6% match plus an additional 4% company-funded contribution

• HSA contributions with wellness incentives

• Annual performance bonuses and merit increase eligibility

• And more—because we invest in your health, your future, and your peace of mind.

It’s a package designed to reward impact—not just hours worked.

More Than Just a Paycheck

At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums.That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.

Learn more about us:

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!

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.