Staff Specialist, Quality (Auditor)

at  Thermo Fisher Scientific

JOB DESCRIPTION

The Staff Specialist, Quality (Corporate CSP Auditor) is responsible for ensuring the Organization’s compliance profile meets global governmental regulatory requirements, corporate policies, group and divisional processes as well as site-level procedures specifically for Controlled Substances. The goal of the Corporate Audit and Controlled Substance Program (CSP) is to identify and highlight compliance gaps, assess remediation needs and improvement opportunities across all of its sites and operations. This empowers management to ensure that appropriate and timely action can be taken to reduce the overall risk to the company.

EDUCATION

• Bachelor of Science (B.Sc.) in chemistry, biology, pharmacy, or other related fields.

EXPERIENCE:

• Minimum ten years of quality management systems work experience within a regulated industry.
• Minimum three years of practical auditing experience within certified quality management systems with performing audits.
• Three years of (R&D, manufacturing, and/or testing) work experience in the field of controlled substances and/or related sectors.
• Experience in quality management-related activities within controlled substances (Narcotics and Precursors/Listed Chemicals).

KNOWLEDGE, SKILLS, ABILITIES:

• Expert level knowledge of controlled substance regulations including but not limited to the US FDA CFR (Part 1300 to End), Health Canada’s Controlled Drugs and Substances Act, Health Canada Narcotic Control and Precursor Control Regulations, UK’s Misuse of Drugs Act, The Controlled Drugs (Drug Precursors) Regulations.
• Experience with methods and techniques related to quality and regulatory, including auditing principles and techniques.
• Knowledge of processes used in the relevant industry’s for storage, manufacturing, testing, and distribution (e.g. inventory accountability, security, record keeping, procedures, etc.).
• Strong oral and written communication, presentation, and technical writing skills (English).
• Capable to conduct remote auditing, when required.
• Lead Auditor certification preferred.
• Ability to travel within the Continental US and Internationally. Typically 30-40% but could range from 30-60% travel requirements based on business needs.

• Conduct audits, gap assessments and other related projects to evaluate the state of quality and regulatory compliance for controlled substances related systems, product documentation and production processes.
• Identify controlled substance compliance gaps and assess the sites’ quality and adherence with corporate policies, site procedures, and all applicable regulatory expectations.
• Perform audit-related tasks, such as scheduling, reviewing technical documentation, assessing corrective action responses, providing feedback, and preparing detailed audit reports.
• Coordinate with team members to run audit projects by developing, maintaining, and completing audit plans.
• Monitor, evaluate, and confirm the effectiveness of corrective and/or preventive actions.
• Analyze audit data, identify systemic compliance issues or gaps, trends, and recommend risk mitigation strategies.
• Provide accurate ongoing assessment by measuring compliance risks by monitoring, tracking and generating detailed trending reports and audit metrics.
• Use change order process to improve and update policies, procedures, work instructions, and templates.
• Keep abreast of government regulations and applicable standards with revised or emerging changes and trends to controlled substance related regulations and industry methodologies.
• Participate with quality and management teams to drive continual improvement.
• Develop and deliver auditor training materials for internal quality auditors.