Quality Investigator 1st Shift

Quva • Sugar Land, TX

3d • Onsite

About The Position

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.

Requirements

• 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
• Ability to work extended and flexible hours (including weekends) when needed
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree