Data Review Specialist

Eurofins USA PSS Insourcing Solutions•Winston-Salem, NC

6d•Onsite

About The Position

Reviews simple routine and non-routine laboratory data for one or more areas according to departmental, corporate and client Standard Operating Procedures, Work Instructions, and/or Forms; read and understand analytical procedures; make sure all work is performed according to ISO17025 guidelines, GLP Regulatory, and GMP Regulatory requirements; Independent auditing of laboratory data to ensure continuous compliance to both the quality system and regulatory requirements. Maintain the highest level of proficiency in terms of those duties and responsibilities as required by auditors/data reviewers. Perform mathematical calculations as part of data review. Interact both directly and indirectly with laboratory staff members to ensure all data review are appropriately and efficiently corrected and documented. Responsible for ensuring the integrity of laboratory data. Communicate in writing and in person with laboratory personnel and/or with the client in an intelligent and clear manner. May assist in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions. May assist in training of laboratory personnel. May assist with Quality and Regulatory Audits and interact directly with auditors. May assist with Technical Writing and/or Report Writing.

Requirements

Bachelor’s degree in chemistry, biology, or other related degree concentration, or equivalent directly-related experience (2 years of directly related industry experience is equivalent to 1 full-time year of college in related major)
Minimum of 2 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience
Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

Reviews simple routine and non-routine laboratory data for one or more areas according to departmental, corporate and client Standard Operating Procedures, Work Instructions, and/or Forms
Read and understand analytical procedures
Make sure all work is performed according to ISO17025 guidelines, GLP Regulatory, and GMP Regulatory requirements
Independent auditing of laboratory data to ensure continuous compliance to both the quality system and regulatory requirements
Maintain the highest level of proficiency in terms of those duties and responsibilities as required by auditors/data reviewers
Perform mathematical calculations as part of data review
Interact both directly and indirectly with laboratory staff members to ensure all data review are appropriately and efficiently corrected and documented
Responsible for ensuring the integrity of laboratory data
Communicate in writing and in person with laboratory personnel and/or with the client in an intelligent and clear manner
May assist in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions
May assist in training of laboratory personnel
May assist with Quality and Regulatory Audits and interact directly with auditors
May assist with Technical Writing and/or Report Writing