Quality Engineer Associate; Controlled Substance Investigator

About the Job

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.

• 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.
• Ensures robustness (complete, accurate and defendable) of all critical and major investigations.
• Ensures all CAPAs are implemented through cGMP systems (e.g. M  revision, training, etc.).
• Monitor and ensure effectiveness checks of CAPAs are conducted Communication and Process Improvements.
• Provide timely updates to management on status of all GMP-related investigations.
• Identifies 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.

• 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.
• Participation in the Daily Management meetings to update leadership on deviation statuses.
• Analytical and problem-solving skills.
• Flexible and able to adapt to company growth and evolving responsibilities.

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. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

Fagron US is proud to be an affirmative action and equal opportunity employer.