Quality Investigator 1st Shift

TX - Sugar Land 1075
1075 W Park One Dr #100
Sugar Land, TX 77478, USA

Our Quality Investigator plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include supporting all stages of manufacturing with conducting and writing incidents and deviation investigations. The candidate will work cross-functionally with Operations and various support groups to investigate root causes, implement effective corrective and preventative actions, and perform thorough product impact analyses.

At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes.

Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

This is a full-time role for our 1st shift, working Monday through Friday from 8:00 AM - 4:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

• Independently author and resolve deviations to meet production and product release requirements
• Communicating across multiple groups and levels to drive deviation closure
• Identifying interdepartmental process improvements and working cross-functionally to-implement them
• Utilizing advanced root cause analysis techniques and technical impact analyses during the deviation investigation process
• Managing multiple priorities either independently or as part of a team to meet key deadlines and communicate issues and progress across all levels of organization
• Communicating (both written and verbal) progress and updates across multiple levels of the organization
• Performing more complex deviation investigations
• Participates in the training process and coaching of new team members and processes
• Helps assist with metric reporting and workload to meet the team’s priorities

• Are detail-oriented with strong verbal and written communications skills
• Expresses energy, shows accountability, multi-tasks and works in a fast-paced, quality-rich environment
• Fulfills expectations, establishes sustainable relationships with team members, maintains effective and meaningful communication channels
• Has good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals
• Understands process flows, gap assessments and analysis of data to drive improvement
• Effectively identifies root causes and implement CAPA

• An associate degree and 3+ years’ cGMP experience OR Bachelor’s degree and 2+ years’ cGMP experience
• Experience with authoring, writing and leading deviation investigations
• Experience working within a production or quality department of a pharmaceutical/ manufacturing company
• Knowledge of continuous improvement techniques and problem-solving skills