Quality Lab Associate III

Quality Lab Associate III

Position Summary
The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of Product, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updates as well as present the strategy for closure of deviations. Manage several investigations at a time.

Job Responsibilities
Determine Product, product impact, root cause and corrective actions for deviations from
manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation.
Conduct personnel interviews to determine root cause of the deviation.
Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
Set up and run meetings with cross functional teams.
Close deviations in a timely manner to meet business and compliance needs.
Work with minimal supervision to drive deviations to closure.
Work with Subject Matter Experts and Quality Approvers to determine the breadth and Product of the investigation to identify the appropriate root cause, implement corrective and preventive actions,
complete trending analysis, and recommend product disposition.
Present and defend investigations during regulatory inspections, as required.
Sustain a clean and safe work area using 6S principles
Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Knowledge, Skill and Abilities
Strong communication and project management skills. Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions, and current Good Manufacturing Practices (cGMPs). Must have good analysis, troubleshooting, and investigation skills. Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report. Must be able to interact with, and influence others at various levels in multiple departments.
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
Must have basic English written and oral communication skills adequate to communicate with other team members.

Required Education and Experience
Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with 2-3 years of experience in root cause evaluation, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry.

Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.