Quality Assurance Specialist - Seasonal - Eurofins USA BioPharma Services

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

The Quality Assurance Specialist will be responsible for routinely reviewing analysis reports to ensure their accuracy, completeness, and compliance with internal/external guidelines.  As part of this review, candidates will identify/initiate CAPAs, Deviations, Change Controls, Process Improvements, and Root Cause Analysis.

• Perform a review of test data as it relates to QC microbiological and/or analytical chemistry testing.
• Review records for GMP compliance and consistency with company policies and procedures necessary to support customers’ quality requirements.
• Maintain data integrity in assigned areas and/or systems and ensure compliance with company SOPs and specifications, as well as FDA, ISO, and cGMP regulations.
• Use computerized systems for approving test results.
• Employ the use of databases and related systems used for tracking various GMP activities.
• Ensure individual training requirements are met and that training records are current.
• Maintain document control and training program records.
• Support quality event investigation activities as directed.
• Support internal audits as necessary
• Participate in training and development activities to advance core competencies  and quality knowledge.
• Actively contribute to the team setting within the laboratory.
• Other duties as assigned by departmental management.

Education:

• A Bachelor's degree in chemistry, biological science, or another related field.

Experience:

• 1 to 3 years of industry experience
• Knowledge of Regulatory Requirements
• Basic understanding of microbiology and/or chemistry-related terms
• Basic understanding of ISO/EN/USP standards and guidelines.
• Some quality-related work experience is preferred.

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed.

• 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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.