Quality Engineer Associate (Controlled Substance Investigator)

Who We Are

Fagron is the global market leader in pharmaceutical medicine, with products sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of personalized medicine.” Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.

About The Role

The Quality Engineer Associate is responsible for the initiation and completion of process deviations investigations aimed at identification of root cause, and implementation of corrective actions to prevent recurrence. This is a development role to expand the knowledge and technical understanding of the investigator as it relates to risk analysis, root cause assessment, and remediation activities.

Responsibilities

• Project management, time management, analytic, and related leadership skills.
• Work on the manufacturing floor and across the site for data gathering from various sources.
• Performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation.
• Work closely with the Quality Engineer to develop investigation skills and expand knowledge of pharmaceutical manufacturing.
• Identification of Corrective and Preventative Actions to reduce deviation recurrence.
• Align internal review team and area subject matter experts on an agreed investigational path forward, author investigations, and support resolution through experimental DOE and execution.
• Ensure robustness (complete, accurate, and defendable) of all critical and major investigations.
• Ensure all CAPAs are implemented through cGMP systems (e.g., MBR revision, training, etc.).
• Monitor and ensure effectiveness checks of CAPAs are conducted.
• Provide timely updates to management on the status of all GMP-related investigations.
• Identify opportunities for operational improvements for both manufacturing, deviation, and investigation management non-conformance events.
• Ownership and implementation of actions related to CAPA, continuous improvement, etc.
• Partner with aseptic operations, post production, and quality to aid in investigations across all functions of the plant.
• Participate in Daily Management meetings to update leadership on deviation statuses.

Qualifications

• Bachelor of Arts/Science preferably in Biochemistry, Chemical Engineering, Biology, or other relevant science discipline or 2 years of experience in manufacturing preferred.
• Investigation experience is required.
• Strong technical writing capability including efficiency using Microsoft Office Suite.
• Familiarity with cGMP working environment and quality systems.
• Ability to manage multiple ongoing projects concurrently.
• Strong meeting facilitation and conflict resolution skills.
• Analytical and problem-solving skills.
• Flexible and able to adapt to company growth and evolving responsibilities.

Benefits

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. The job opportunity includes:

• Competitive salary
• Comprehensive benefits
• Performance package
• Ability to be part of an international leader in an expanding industry