Quality Assurance Data Reviewer II/III

Responsibilities

• Review QC Analytical and Manufacturing batch record data — Perform thorough review of raw data, calculations, instrument outputs, and final reports for accuracy, completeness, and compliance with internal SOPs and regulatory requirements.
• Ensure Data Integrity — Verify ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) across all data documentation.
• Audit Laboratory Records — Review laboratory notebooks, worksheets, chromatograms, and electronic data from systems such as Empower, LIMS, or ELN.
• Identify and Escalate Issues — Detect data discrepancies, deviations, out-of-specification (OOS) or out-of-trend (OOT) results, and ensure proper documentation and investigation.
• Support Batch Release — Provide timely QA approval of QC data packages and batch record data to support product disposition and manufacturing timelines.
• Collaborate with QC and QA Teams — Work closely with QC analysts, supervisors, and QA colleagues to resolve data issues and improve documentation practices.
• Participate in Continuous Improvement — Contribute to updates of SOPs, data review checklists, and quality systems to enhance compliance and efficiency.
• Maintain Regulatory Compliance — Ensure all reviewed data meets FDA, EMA, ICH, and GMP expectations for laboratory controls and documentation
• Tracking of Quality Records — Assist with monitoring, communicating and progressing quality records to ensure timely execution and closure of quality records, CAPAs, Change Control, Deviations etc.

Skills required

• Strong understanding of GxP regulations, ICH guidelines, and global regulatory frameworks.
• Excellent communication, documentation, and stakeholder‑management abilities.
• Analytical thinking with the ability to interpret quality data and identify trends.
• Strong written and verbal communication, organizational and prioritization skills.
• Ability to handle multiple priorities in a project driven environment.
• Ability to maintain a flexible and a customer-oriented approach to problem-solving.
• Ability to maintain detailed and accurate records.
• Familiarity with electronic Quality Manage Systems, (DOT compliance, Veeva, Trackwise etc)
• Nice to have, experience with reviewing raw data and audit trails within Chromatography Data Systems (Empower, OpenLab, Galaxie) for HPLC and GC analysis etc

Education and experience

• BS in scientific or related discipline.
• Minimum 3 - 5 years cGMP experience in Quality Assurance/Quality Control depending on level.
• Industry experiences in medical devices ISO 13485 and/or FDA 21 CFR regulations for Drug Product manufacturing.
• Proficient in the use of a wide variety of computer applications including the MS office, Excel, data base management systems, and project management software.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times

Compensation

The hourly rate for this role starts at $46. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health benefits and an annual target bonus for full-time positions.