Pharmaceutical Compliance Specialist
Eurofins PSS works with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries. For 20 years the international network of teams has served clients at their sites across 20 countries. PSS® is part of Eurofins Scientific, an international life‑sciences company with a network of over 950 laboratories in 60 countries and approximately 63 000 employees.
About the role
The role develops a comprehensive set of quality metrics aligned with organizational goals and industry standards, collaborates with cross‑functional client Quality and PSS site teams, collects and analyzes data from process areas, defect reports and performance metrics, and generates regular investigation and training reports to provide visibility into quality performance. The incumbent manages quality‑improvement activities, presents metrics and insights to stakeholders, evaluates resources and training needs, works in a GMP‑regulated environment, and drives continuous‑improvement efforts aligned with GMP and FDA requirements.
Responsibilities
- Develop and align quality metrics with organizational goals and industry standards.
- Collaborate with cross‑functional client Quality and other PSS site teams.
- Collect data from various process areas, defect reports, and performance metrics.
- Analyze data to identify trends, patterns, and areas for improvement.
- Generate regular investigation and training reports to provide visibility into quality performance.
- Manage quality‑improvement activities, meetings, and related support tasks.
- Present and communicate quality‑related metrics, trends, and insights to stakeholders at all organizational levels.
- Present findings in meetings, reviews, and reports to facilitate informed decision‑making.
- Evaluate and manage resources and task assignments, implementing capacity‑model systems and cross‑functional training.
- Work in a GMP‑regulated environment to support implementation of quality‑related activities.
- Assist with administrative and operational aspects of quality improvement as needed.
- Drive continuous‑improvement efforts through monitoring and evaluation of site systems and processes in line with GMP and FDA requirements.
- Evaluate the thoroughness and effectiveness of the training program.
- Foster a culture of quality awareness and continuous improvement throughout the organization.
- Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.
- Apply GMP/GLP in all areas of responsibility, as appropriate.
- Demonstrate and promote the company’s vision.
- Maintain regular attendance and punctuality.
- Ensure the quality policy program is understood, implemented, and maintained at all levels; identify, prevent, or correct departures from the quality system.
- Coordinate workflow and perform daily monitoring to meet turnaround‑time (TAT) goals.
- Perform and/or assign other duties as requested to ensure smooth department operations.
Qualifications
- Bachelor’s degree + 2 years of relevant industry experience, or Master’s degree in a scientific field (Pharmacy, Biology, Chemistry) + 1 year of relevant experience.
- Relevant experience may include quality investigations, deviations, audits, CAPAs, quality management systems, controlled document storage, etc.
- Pharmaceutical industry experience.
- Strong knowledge of global regulatory and cGMP requirements and industry best practices.
- Experience with manufacturing operations.
- Strong technical writing ability.
Pay
Pay range: $26.25 – $30.00 per hour
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Eligibility for potential yearly bonus and merit‑based pay increases
Schedule
Full‑time, Monday‑Friday, 8:00 AM – 4:30 PM