Data Reviewer, Biopharma

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Maintain the integrity and quality of laboratory and chromatographic data and reports.

• Ensure that analyses adhere to validated or experimental analytical procedures, comparing results against methodologies, protocols, product specifications, SOP acceptance criteria, and GMP standards.

• Review data entered into databases and reports, monitoring the quality of laboratory data.

• Assess chromatographic data, associated notebooks, and sample results for scientific validity, completeness, accurate data representation, and final reported outcomes.

• Evaluate data for adherence to analytical methods, client requirements, GLP, and GMP guidelines.

• Provide clear and concise review findings that highlight deficiencies in analytical data or reports.

• Collaborate with laboratory personnel to proactively enhance the quality of laboratory documentation.

• Develop QC statements that identify shortcomings in analytical datasets or notebooks.

• Inform the project leader about deficiencies for necessary corrections.

• Facilitate conversations with laboratory staff regarding best practices in documentation and quality issues.

• Advocate for quality and improvements in review processes.

• Identify and promote process enhancement initiatives.

⛳️ Requirements

• Bachelor’s degree in Science or a related field is required.

• A minimum of 2 years of QA/QC analytical experience is essential.

• Comprehensive knowledge of chromatography, including the review of analytical data and results.

• In-depth understanding of SOPs and Federal Regulations, including GLP and GMP.

• Excellent verbal and written communication skills.

• Strong technical expertise in laboratory procedures, methodologies, and standards.

• Capability to independently review laboratory reports and analytical methods.

• High attention to detail.

• Ability to provide clear and concise feedback and documentation of results.

• Skill in communicating, receiving, and comprehending information and ideas with diverse groups of individuals.

• Ability to remain upright and stationary and/or standing during typical working hours.

• Capacity to lift and move objects weighing up to 25 pounds.

• Flexibility to work in non-traditional work environments.

• Proficiency in using and learning standard office equipment and technology.

• Ability to perform successfully under pressure while managing multiple projects or activities.

🏝️ Benefits

• Immigration and visa support for successful applicants and their dependents.

• Tax consultations.

• Additional basic destination services.

• Reasonable accommodations for individuals with disabilities.

• Equal opportunity employment.