Data Review Specialist responsibilities include, but are not limited to, the following:
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Applies the highest quality standard in all areas of responsibility
- Demonstrates and promotes the company vision
- Demonstrates strong client service skills, teamwork, and collaboration
- Proactively plans and multitasks to maximize productivity
- Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
- Regular attendance and punctuality
- Applies 17025 compliance standards in all areas of responsibility, as appropriate
- Possesses strong organizational skills
- Provides clear feedback
- Keeps accurate records, follows instructions, and complies with company policies
- Proactively checks and stays current with all training across multiple learning platforms
- Accepts responsibility for data integrity checks and defends all data approved
- Pays attention to details and remains very organized at all times
- Exhibits a high-level of professionalism and strong interpersonal skills
- Challenges others’ work without being intimidated, but able to remain professional
- Remains flexible and shift priorities quickly
- Produces internal routine and non-routine data reports for clients
- Reviews and audits the most complex and novel laboratory data one or more areas (including MDV) according to departmental, corporate and client SOPs, Work Instructions, and/or Forms; reads and understands analytical procedures
- Maintains the highest level of proficiency in terms of those duties and responsibilities as required auditors/data reviewers
- Performs mathematical calculations as part of data review
- Interacts both directly and indirectly with laboratory staff members to ensure all data review are appropriately and efficiently corrected and documented
- Assists with Technical Writing and/or Report Writing
- Assists in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions
- Assists in training of laboratory personnel
- Assists with Quality and Regulatory Audits and interact directly with auditors
- Maintains continuous learning to keep abreast if regulatory or industry standards as related to data review requirements
- Identifies potential quality system improvements to maximize quality and productivity
- Serves as SME in training of laboratory personnel
- Communicates effectively with client staff members
- Conducts all activities in a safe and efficient manner
- Performs other duties as assigned