Senior Quality Specialist

Eurofins • Lancaster, PA

1d • Onsite

About The Position

Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries to ensure products are safe, healthier, and more sustainable. The company is a global leader in food, environment, pharmaceutical, and cosmetic product testing, as well as agroscience Contract Research Organisation services. With a network of 900 laboratories in over 54 countries and 58,000 staff, Eurofins offers over 200,000 analytical methods. This specific role is within the Quality Assurance (QA) Department and will be directly involved in Client Audits, which are crucial for confirming compliance with regulations, data quality, and project requirements. Client visits can range from facility tours to intensive inspections of technical operations and regulatory compliance.

Requirements

• Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• Minimum of three years of Pharmaceutical industry experience with knowledge of regulatory requirements
• Computer skills including word processing, spreadsheets, PowerPoint and database
• Experience with cGMP and/or FDA regulated environments
• Authorization to work in the United States indefinitely without restriction or sponsorship

Nice To Haves

• Technical writing experience
• Previous experience in client audits as well as internal audits
• Previous experience in Pharmaceutical Quality Assurance or Regulatory Compliance

Responsibilities

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Serving as an audit host / escort
• Answering questions about laboratory and quality systems, and regulatory compliance
• Taking notes throughout an Audit visit to document the scope of the audit and items that need to be addressed
• Communicating audit issues to senior management
• Providing formal written responses to client audit reports
• Ensuring follow-up to cited items is performed in a timely manner
• Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
• Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
• Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process

Benefits

• Comprehensive medical coverage
• dental
• vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation
• holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior