Principal Engineering Investigator

Principal Engineering Investigator exists to ensure the accuracy integrity and timeliness of all technical investigations and CAPAs associated with sterile compounding and injectable manufacturing operations. This role is accountable for collaborating with the team that identifies true root causes develops effective and implements sustainable corrective / preventive actions and communicates results that withstand regulatory scrutiny. The role is pivotal in supporting continuous improvement initiatives that enhance and transform the quality compliance and operational efficiency while fostering a strong culture of accountability and excellence across Quva. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Principal Engineering Investigator Does Each Day :

• Lead end-to-end analytical and manufacturing-related investigations including out-of-specification (OOS) out-of-trend (OOT) analytical deviations data anomalies and lab incidents
• Ensure investigations are scientifically sound compliant and completed within defined timelines meeting all cGMP and regulatory expectations (FDA EMA USP

and 503B guidance)

Our Most Successful Principal Engineering Investigator :

Minimum Requirements for this Role :

Any of the Following Will Give You an Edge :

Benefits of Working at Quva :

About Quva :

Quva provides industry-leading health-system pharmacy services and solutions including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of Pharmas multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStreampartners with health systems to aggregate normalize and analyze large amounts of complex data across their sites of care and through proprietary machine learning transforms data into actionable insights supporting revenue optimization script capture inventory management drug shortage control and more. Quvas overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quvas Equal Opportunity Policy prohibits harassment or discrimination due to age ancestry color disability gender gender expression gender identity genetic information marital status medical condition military or veteran status national origin race religious creed sex (including pregnancy childbirth breastfeeding and any related medical conditions) sexual orientation and any other characteristic or classification protected by applicable laws. All employment with Quva is at will.

Required Experience :

Staff IC

Key Skills

Epidemiology,Public Health,Bank Secrecy Act,Bioinformatics,Fraud,Genetics,Interviewing,Law Enforcement,Qualitative Research Interviewing,Research Experience,Next Generation Sequencing,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1