Pharmaceutical Compliance Specialist

About the role

Eurofins PSS works with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries. 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 analytical testing services through a network of over 950 laboratories in 60 countries with approximately 63,000 employees.

Responsibilities

• Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards by collaborating with stakeholders to identify key performance indications (KPIs) and defining 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 the 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 the work of the departments
• Present and communicate quality-related metrics, trends, and insights to stakeholders at various levels of the organization; present findings in meetings, reviews, and reports to facilitate informed decision making
• Evaluate and manage resources and tasks—understanding 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 to 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

QA essential duties

• Apply GMP/GLP in all areas of responsibility, as appropriate
• Demonstrate and promote the company's vision
• Maintain regular attendance and punctuality
• Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; 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 the smooth operations of department

Qualifications

• Bachelor's degree + 2 years of relevant industry experience, or Master's degree in a scientific field such as Pharmacy, Biology, or Chemistry
• Pharmaceutical industry experience
• Strong knowledge of global regulatory and cGMP requirements, industry best practices
• Experience with manufacturing operations
• Strong technical writing ability

Schedule

Full-time, Monday-Friday, 8:00 AM - 4:30 PM

Pay

$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