Pharmaceutical Compliance Specialist

Company Description

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.

Job Description

• Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
• Collaborating with cross functional client Quality and other PSS site team.
• Collecting data from various process areas, defect reports and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.
• Generate regular investigation, training reports to provide visibility into quality performance. Manage quality improvement activities, meetings and other activities supporting the work of the departments.
• Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision making.
• Evaluate and managing resources and task- 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 continues improvement throughout the organization.
• Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.

QA Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrates and promotes the company's vision
• 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 + 2 years of relevant industry experience, or Master's degree in a scientific field such as Pharmacy, Biology or 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, industry best-practices
• Experience with manufacturing operations.
• Strong technical writing ability

Additional Information

• Position is full-time, Monday-Friday, 8:00 AM - 4:30 PM
• Pay range: $26.25 - $30.00
• Excellent full-time benefits including 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 & Merit-Based Pay Increases
• LinkedIn: #LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.