• Investigate and write investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology.
• Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
• Must have strong writing skills to present findings in a clear and concise manner.
• Must be detail-oriented and able to demonstrate a high standard of integrity.
• Must have a desire to demonstrate excellence by setting high standards.
• BS/BA degree and a minimum of 2-3 years of relevant experience. QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).
Specific Job Requirements
Performs a variety of activities to ensure compliance with applicable regulatory requirements. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives. Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support. Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. May conduct or serve as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products. Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required. Interfaces with contract manufacturers and suppliers to address documentation and compliance issues. Normally receives general instruction on routine work, detailed instructions on new assignments.
Must have an understanding and application of QA principles, concepts, industry practices, and standards. Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis. With guidance exercises judgment within well-defined and established procedures and practices to determine appropriate action. Normally receives no instruction on routine work, general instructions on new assignments. Strong verbal, technical writing, time management and interpersonal skills are required.