Senior Quality Investigator 2nd Shift

QuVa Pharma Inc.
Bloomsbury, NJ Full Time
POSTED ON 5/13/2024

Our Senior 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 be supporting all stages of manufacturing by conducting and writing incidents and deviation investigations.  This person 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.  Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Senior Quality Investigator Does Each Day:

  • Independently authors and resolves deviations in order to meet production and product release requirements
  • Communicates across multiple groups and levels to drive deviation closure
  • Identifies interdepartmental process improvements and working cross-functionally to-implement them
  • Uses advanced root cause analysis techniques and technical impact analyses during the deviation investigation process
  • Manages multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
  • Communicates(both written and verbal) progress and updates across multiple levels of the organization
  • Performs 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

Our Most Successful Senior Quality Investigators:

  • Has excellent written and verbal communication skills
  • Prioritizes, handles, and tracks multiple assignments
  • Collaborates in a team environment
  • Has strong analytical skills with a detail-oriented and task-focused outlook
  • Strong organizational and time management skills
  • Is proficient in MS Office, especially Excel, Word, Outlook, and PowerPoint
  • Understands process flows, gap assessments and analysis of data to drive improvement
  • Identifies root causes and implement CAPA

Minimum Requirements for this Role:

  • A Bachelor’s degree in life science or related field
  • 3 years’ related experience with 1 years in investigations preferably in pharmaceutical industry
  • 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
  • Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas

Benefits of Working at QuVa:

  • 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
  • Occasional weekend and overtime opportunities with advance notice
  • National, industry-leading high growth company with future career advancement opportunities

About QuVa:

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.

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. QuVa's 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.”

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