Quality GxP Auditor - 3229SS

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements:

The Quality and Regulatory family of roles is involved at every step in the product lifecycle chain. The primary responsibilities of this job family is to provide guidance, assess current state and execute project deliverables based upon experience, client requirements and a comprehensive understanding of federal regulatory requirements and ICH (International Council for Harmonization) guidance. The roles within this job family will work to identify, address, and mitigate regulatory & compliance issues for clients. These individuals will assist clients to return or reach conformity through the implementation and/or enhancement of the site’s Quality Management System (QMS) while ensuring conformance to FDA and international regulations and standards. The roles within this job family may work in concert with the client or as part of a Verista team and will ensure deliverables are accurately prepared to meet internal and external quality standards, are accurately presented, and efficiently closed out.

The Investigator is responsible to conduct and document investigations relating to non-conformances and/or complaints within a GMP Pharmaceutical packaging organization. The Investigator will utilize root cause analysis tools, critical thinking and interviewing techniques to determine the root and contributing causal factors of non-conformances/complaints. The Investigator will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation. The Investigator will lead, as necessary, the implementation of associated corrective and preventative actions through collaboration, teamwork and influence. The position will work closely and in collaboration with internal and occasionally external stakeholders. The Investigator also has responsibilities for data generation, process evaluation and performance metrics for the purposes of customer communication and driving continuous improvements.

Requirements

You will have:

• B.S./B.A. in scientific discipline as a minimum.
• Minimum of +5 years of experience within Pharmaceutical / Biotech / Medical Device industry.
• Demonstrated success in earning and maintaining a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
• Experience with Customer Complaint Investigations.
• Proven record of teamwork, problem solving, project tracking and facilitation of efficient communication between the client and the team.
• Experience creating and working with high performance and high demand teams.
• Quality orientation and high attention to detail.
• Demonstrated ability to work with others and drive results.
• Ability to think ahead and prepare sound action plans to achieve results.

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Benefits