Data Review Specialist

Data Reviewer responsibilities include, but are not limited to, the following:

• 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 continous 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 to1 full-time year of college in related major).
• Minimum of 2 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience
• Experience in a cGMP and/or ISO 17025 environment
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Authorization to work in the United States indefinitely without restriction or sponsorship