QC Technical Transfer Specialist

Responsibilities

• Perform analytical testing for raw materials, in-process samples, finished products, stability samples, and lot release testing.
• Execute analytical methods following Good Manufacturing Practices (GMP) guidelines.
• Support analytical method transfers between laboratories.
• Afford assistance in method validation and verification activities.
• Review laboratory data for accuracy and completeness.
• Investigate laboratory deviations and Out-of-Specification (OOS) results.
• Prepare and maintain Good Manufacturing Practices (GMP) documentation.
• Support Change Controls, Corrective Actions Plans (CAPAs), Deviations, and Investigations.
• Conduct root cause analysis and implement corrective actions.
• Maintain laboratory instruments and equipment.
• Utilize laboratory software including Laboratory Information Management Systems (LIMS), Empower, SoftMax Pro, SoloVPE, and TrackWise.
• Support software validation and Computerized System Validation (CSV) activities.
• Ensure compliance with Current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), Analytical Laboratory Standard Operating Procedures (ALCOA+), and Data Integrity principles.
• Participate in audits and inspection readiness.
• Collaborate with Quality Assurance (QA), Manufacturing, Validation, and Engineering teams.
• Train laboratory personnel on procedures and systems when required.