FSP – QC Reviewer – Data Review

Key Responsibilities

• Perform data review and reporting activities supporting release, stability, qualification, transfer, and validation activities in accordance with approved procedures.
• Identify trends, patterns, or issues in the data and communicate findings to support timely review and approval activities.
• Identify and escalate discrepancies, documentation issues, and potential data integrity concerns.
• Support review metrics collection and data trending activities.
• Participate in document revisions, process harmonization efforts and continuous improvement efforts.
• Support deviations, investigations, and CAPAs associated with data review and governance.
• Support regulatory submissions, inspections, and health authority responses through authoring, QC data review, technical assessments, and preparation of supporting documentation.
• Perform QC data verification activities to ensure accuracy and completeness and compliance of records.
• Demonstrate working knowledge of GMP requirements, data integrity principles, and quality systems.
• Collaborate effectively with QC leads, laboratories, and cross-functional partners.

Education and Experience

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or similar.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years').

Knowledge, Skills and Abilities

• Perform data review and reporting activities supporting release, stability, qualification, transfer, and validation activities in accordance with approved procedures.
• Identify trends, patterns, or issues in the data and communicate findings to support timely review and approval activities.
• Identify and escalate discrepancies, documentation issues, and potential data integrity concerns.
• Support review metrics collection and data trending activities.
• Participate in document revisions, process harmonization efforts and continuous improvement efforts.
• Support deviations, investigations, and CAPAs associated with data review and governance.
• Support regulatory submissions, inspections, and health authority responses through authoring, QC data review, technical assessments, and preparation of supporting documentation.
• Perform QC data verification activities to ensure accuracy and completeness and compliance of records.
• Demonstrate working knowledge of GMP requirements, data integrity principles, and quality systems.
• Collaborate effectively with QC leads, laboratories, and cross-functional partners.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.