Job Description

Duties:

• Works independently to provide quality assurance oversight in areas responsible for adhering to current Good Manufacturing Practices (cGMPs), including Quality Control Systems.
• Demonstrates a high level of independent judgment and discretion in the timely identification, investigation, and resolution of events impacting the quality of products and processes.
• Ensures adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and ensuring documentation and investigations meet all requirements.
• Makes difficult decisions with little time for deliberation, with potential direct impact on active manufacturing operations, the release of equipment, systems, or areas.
• Provides quality oversight to the change management system for complex Minor and/or Major classified Change Controls, including plan creation oversight and ensuring adherence to local SOPs and regulatory compliance.
• Performs independent technical review of documentation during and post-execution of cGMP activities, ensuring all specifications are met and applicable requirements are completed and acceptable.
• Ensures all issues/documentation associated with each process in the assigned area have been resolved and approved prior to release to the next step, in compliance with cGMPs, SOPs, and current manufacturing regulations and site procedures.
• Analyzes and reports findings to appropriate departments.

• Some Team Lead and/or Supervisory experience.
• Attention to detail, good organizational and interpersonal skills, and problem-solving skills.
• Ability to prioritize and work under pressure.
• Ability to work effectively and respond quickly in a fast-paced environment.
• Demonstrated proficiency in MS Office (MS Word and Excel) and associated computer programs.
• Knowledge of SAP.
• Technical knowledge of manufacturing systems, methods, and procedures.
• Excellent written and verbal communication skills.
• Awareness and understanding of manufacturing processes.

• Bachelor’s degree in Life Sciences or Engineering

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