Pharmaceutical Compliance Specialist
Eurofins · Rensselaer, NY · 1 mo ago
Finance$26.25–$30/hrFull-time
At Eurofins PSS, we work with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries - who all trust us with their mission-critical testing. For 20 years, our international network of teams have served clients at their sites, across 20 countries. PSS® is part of Eurofins Scientific, an international life sciences company, providing a unique range of analytical testing services across multiple industries, through a network of over 950 laboratories in 60 countries, and c.a. 63,000 employees.
Responsibilities
- Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards; collaborate with stakeholders to identify key performance indications (KPIs) and define measurable objectives.
- 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 of improvement.
- Generate regular investigation and training reports to provide visibility into quality performance.
- Manage quality improvement activities, meetings, and other activities supporting department work.
- Present and communicate quality‑related metrics, trends, and insights to stakeholders at various organizational levels.
- Present findings in meetings, reviews, and reports to facilitate informed decision making.
- Evaluate and manage resources and tasks; understand department needs to evaluate resources needed by implementing the Capacity model system and cross‑functional training.
- Work in a GMP‑regulated environment to provide and assist in the implementation of quality‑related activities.
- Assist with other aspects of quality improvement including administrative and operational support as needed.
- Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements.
- Ensure adherence with quality standards and best practices.
- 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 any departures from the quality system.
- Coordinate workflow and perform daily monitoring to meet TAT.
- 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.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
- Eligibility for potential yearly bonus and merit‑based pay increases.
Pay
$26.25 - $30.00 per hour
Schedule
Full-time, Monday‑Friday, 8:00 AM – 4:30 PM