Analyst IV - Dossier Data Integrity, Quality Control Operations

Overview:
The Analyst IV – Dossier Data Integrity, Quality Control Operations ensures the integrity, completeness, and accuracy of regulatory filings, laboratory data, and reports to maintain the highest standards of quality and compliance. This role supports commercialization efforts through meticulous review and verification of data, ensuring alignment with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).

Key Responsibilities:

• Verify the integrity and traceability of regulatory dossier sections by reviewing them against reference methods and reports.
• Review analytical data to ensure accuracy, correct transcription, and completeness of associated references.
• Audit laboratory notebooks, worksheets, logbooks, and electronic data for compliance and accuracy.
• Ensure adherence to approved protocols during analytical method validation, verification, and transfer testing.
• Audit electronic data and associated documentation, ensuring alignment with applicable procedures and SOPs.
• Address discrepancies or deviations by working directly with clients to implement required corrections.
• Prioritize tasks in collaboration with management and provide feedback to enhance review processes.
• Adhere to SOPs, cGMP standards, and quality control guidelines in all responsibilities.
• Communicate findings, deviations, and suggestions to management effectively.
• Support continuous improvement initiatives for data integrity and review processes.
• Perform additional tasks as assigned by management.

Skills:

• Data Integrity
• GMP Compliance
• Transcription and Data Accuracy
• Technical Writing and Documentation
• Organizational Skills
• Data Analysis and Problem-Solving
• Regulatory Filings and Audits

Requirements

Qualifications:

• Bachelor’s degree in chemistry, biology, biochemistry, or a related scientific field.
• Minimum of 5 years of experience in a GMP Quality Control function or equivalent, with demonstrated progression in responsibilities.
• Strong technical writing skills, particularly in investigations and regulatory submissions.
• Experience in analytical method transfer, implementation, and lifecycle management.
• Proficient in data analysis, interpretation, and problem-solving with a focus on data integrity and CAPA implementation.
• Skilled in organizational and time-management abilities to handle multiple priorities.
• Excellent communication and collaboration skills to work effectively in cross-functional teams.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Preferred Skills:

• Knowledge of cGMP and SOPs
• Familiarity with LabWare LIMS and method validation
• Proficiency in Microsoft Excel, Word, and PowerPoint

Schedule:

• Hours Per Week: 40 hours (8 hours/day)