Pharmaceutical Compliance Specialist

  • Full-time
  • Compensation: USD 26.25 - USD 30.00 - hourly

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 
  • 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.

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