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Quality Assurance Investigator
2 months ago
Onsite Deviation Investigator
Trinity Consultants - Advent Engineering is a premier engineering and consulting firm dedicated to serving the pharmaceutical and biotechnology sectors. With a robust presence across North America and Asia, our organization plays a pivotal role in the design and engineering of pharmaceutical facilities and quality systems.
Our comprehensive services encompass process engineering, automation solutions, project management, facility design, startup and commissioning, as well as validation and compliance consulting for leading pharmaceutical and biotechnology manufacturers.
The ideal candidate will collaborate with a team of engineers focused on the design, automation, commissioning, and initiation of various processes and systems. A blend of strong technical skills, automation engineering expertise, and technical documentation proficiency is essential.
Key Responsibilities:
- Conducting, leading, and managing thorough investigations.
- Performing fact-finding missions, assessing situations, determining root causes (RCA), generating corrective and preventive actions (CAPAs), and coordinating cross-functional teams.
- Demonstrating a high level of understanding of cGMP biopharmaceutical manufacturing processes, including upstream and downstream processes, and familiarity with systems such as UF/DF, chromatography, bioreactors, and disposable technologies.
- Exhibiting a strong grasp of metrology, maintenance systems, preventative maintenance, HVAC, and pharmaceutical-grade utilities.
- Accountable for developing and monitoring performance metrics.
- Keeping abreast of current good manufacturing practices (cGXPs).
Required Knowledge, Skills, and Abilities:
- Understanding of drug product manufacturing from formulation to final packaging.
- Basic knowledge of regulatory compliance, including cGMP, FDA regulations, and familiarity with ICH and EU guidelines.
- Proficiency in Microsoft Office Suite, including Excel, PowerPoint, Visio, and Word, along with experience in collaborative work environments.
- Excellent interpersonal, written, and verbal communication skills.
- Demonstrating confidence, high emotional intelligence, and the ability to provide updates to team members effectively.
- Exhibiting resilience and adaptability in challenging situations and under tight deadlines.
- Listening to and understanding the needs of team members and stakeholders to foster a productive team environment.
Education and Experience:
- A minimum of a Bachelor’s degree in a scientific or engineering discipline, accompanied by 3+ years of relevant experience in investigations and cGMP manufacturing operations.
