Staff Auditor II

UPS

4d • Hybrid

About The Position

The Audit Supervisor position will require the ideal candidate to have a strong working knowledge in many facets of pharmaceutical and medical device compliance (manufacturing, receipt, distribution, warehousing, order fulfillment). The position is responsible for developing audit methodologies for evaluating internal controls over healthcare processes within our logistic and distribution operations in an effort to ensure compliance with internal policies and applicable government regulations. They also prepare reports for all levels of management. The Audit Supervisor is responsible for implementing and maintaining comprehensive risk based GxP compliance audit programs in the pharmaceutical and medical device sectors. They create audit schedules (e.g., availability of personnel and data, timing requirements, etc.) to ensure completion within required guidelines and review audit findings to ensure identified weaknesses and deficiencies are properly vetted and resolved. The Staff Auditor II gathers information from various groups to prepare and distribute audit reports to all levels of management.

Requirements

• 3+ years of relevant pharmaceutical, medical device and/or dietary supplement industry experience within the logistics and distribution and/or manufacturing environments, including 2+ years of GxP auditing experience
• Working knowledge of QA oversight for pharmaceutical and medical device logistics & distribution, manufacturing, and/or pharmaceutical trials, with the ability to utilize data analytics to interpret data and analyze results
• Documented experience in managing, using CAPA/nonconformance systems.
• Detail Oriented: Distinguishes between “big picture” concepts and specialized, smaller specific facts associated with work; notes the specifics of events and experiences; explains, in general, how details impact end goals or outcomes; ensures that work is completed accurately and with the appropriate level of detail
• Ability to build effective working relationships at all levels with diverse internal audit and external stakeholders
• Working knowledge of 21 CFR parts 820, 210, 211, 111, 11 and ISO 9001:2015 and 13485:2016
• Data analysis tools: The Center of Excellence Audit Supervisor should be familiar with data analysis tools such as Excel, SQL, and specialized audit software such as IDEA, ACL, or PowerBI.
• Data Visualization: The Center of Excellence Audit Supervisor should be able to create visualizations that present data in a clear and concise manner with tools such as Tableau, PowerBI, or Excel.
• Data Mining: The Center of Excellence Audit Supervisor should be able to extract meaningful insights from large datasets by identifying patterns, trends, and anomalies.
• Risk Assessment: The Center of Excellence Audit Supervisor should be able to use data analytics to identify and assess risks within the organization.
• Fraud Detection: The Center of Excellence Supervisor should be able to use data analytics to identify potential fraud within the organization. This requires a knowledge of fraud schemes and the ability to analyze data to detect patterns indicative of fraud.
• Leadership and management skills: The Center of Excellence Audit Supervisor should be able to lead teams of auditors, manage project timelines and budgets, and communicate effectively with stakeholders.
• Communication skills: The Center of Excellence Audit Supervisor should be able to communicate complex audit findings to non-technical stakeholders in a clear and concise manner.
• Problem-solving skills: The Center of Excellence Audit Supervisor should be able to identify problems and develop solutions to address them, often in a fast-paced environment.
• Attention to detail: The Center of Excellence Audit Supervisor should have a keen eye for detail to ensure that audit findings are accurate and complete.
• Bachelor’s Degree (or internationally comparable degree) in Natural Sciences (Biology, Chemistry, etc.) is required for this role.
• Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer.

Nice To Haves

• A professional certification such as Certified Quality Auditor or Certified Medical Device Auditor is preferred.

Responsibilities

• Determine objectives and risks of core and support processes that support a business strategy using the Business Process Review methodology; create process maps, and use data/metrics to measure the risk within the process and the impact of controls on the process opportunities; evaluate effectiveness of controls; identify sustainable solutions to fix breakdowns
• Identify sources of data (operational, financial, industry, etc.); gather, analyze and manipulate data; review data for trends and exceptions and draw sound conclusions; use statistical data tools to graphically display and analyze results; review and create cost/benefit analysis and financial/data models.
• Identifies individual and team skill gaps and developmental opportunities (e.g., training, special assignments, conferences, projects, etc.) to facilitate individual and team development
• Accept and facilitate change by understanding the vision. Responsible for continuously improving the internal audit function. They review and assess the effectiveness of the internal audit process and identify areas for improvement.
• Effectively communicate audit results, and recommendations to senior management, and work with management to develop action plans to address identified issues.
• Resolves individual and group performance issues in accordance with UPS’s policies and procedures in a timely manner to motivate and foster teamwork

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level