Quality Assurance Specialist

Company Description

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.

Job Description

Primary Duties and Responsibilities:

As Quality Assurance Specialist I (QAS I), this role is responsible, as a member of the Quality Assurance Unit (QAU), for assuring that the quality assurance programs are maintained in accordance to pertinent regulatory requirements in the performance of the duties of this position.

Essential Duties and Responsibilities:

•  Provides on-the-floor day to day Quality support to laboratory operations.
•  Ability to perform final review of validation and sample analysis data.
•  Reviews and interacts with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
• Collaborates with departments to ensure that all review activities are executed efficiently and effectively.
• Identifies and implements process improvements, as necessary.

• Ability to interpret Quality standards for implementation, and provide training as needed.

• Ability to communicate clearly and professionally both in writing and verbally.

•  Flexibility in problem solving and work hours to meet business objectives.

• Assures quality policies and procedures are maintained, reviewed for effectiveness, and revised as needed in order to advance the quality of processes, procedures, and deliverables to clients while complying with regulatory requirements.

• Reviews, reconciles all supporting documentation within a study file to assure the file is complete, organized to facilitate reconstruction and is properly archived as specified by site written SOPs

• Performs other duties as assigned

• Owns the accountability and responsibility of delivering to client needs and timeliness

• Provides cross-functional support to other departments as required

• May serve as technical advisor for analysts with regard to QA/QC of data

• Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns

Qualifications

Education and Experience:

• Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related ENVIRONMENTAL LAB experience is equivalent to one full-time year of college in related major)
• At least three years of laboratory experience with knowledge of regulatory requirements
• Authorization to work in the United States indefinitely without restriction or sponsorship

• Strong communication skills
• Strong work ethic
• Detail oriented

Additional Information

Position is full-time, Monday - Friday 8:00 AM - 5:00 PM.  Candidates currently living within a commutable distance of company / lab facility in Edison, NJ are encouraged to apply.

• 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

Our top priority is the health and safety of our employees. You will be briefed on all of our Covid-19 measures and processes in place that are followed through-roughly to make sure the safety of our teammates and operations.

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

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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirm