Responsibilities:

• Technical review of raw data for the QC group
• Technical review of method transfer/verification protocols
• Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols
• Review, manage, and monitor stability trend tables
• Support investigations that arise in the QC testing of raw materials/finished products as needed
• Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scope of the investigation to determine the appropriate root cause
• Support the implementation of corrective actions, complete the trending analysis and determine product disposition as applicable
• This role will foster a collaborative relationship with manufacturing and laboratory personnel focused on high quality systematic investigations, meaningful corrective actions, and reducing the deviation generation rate. Provide support to determine appropriate corrective actions to prevent re-occurrence of the deviation
• Track effective measure of each implemented corrective action and take appropriate action if and when required
• Provides oversight and final review of investigations to ensure adherence to cGMP, rigorous technical content, investigation clarity and completeness
• Provide training to department employees as required stemming from deviations and/or laboratory investigations.
• Perform other duties as assigned

Requirements:

• BS degree Life Sciences
• 1-3 years of experience in cGMP Pharma/Biotech environment
• Prior experience with review of analytical data and test methods