Quality & Compliance Specialist I

Role Title Quality & Compliance Specialist I

Department Quality

Supervisor Senior QA Manager

FLSA Exempt

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

FUNCTION SUMMARY Quality & Compliance Specialist I

The Quality and Compliance Specialist I is responsible for ensuring the Company’s quality management system is functioning properly. They may work with a team of other professionals to develop and implement procedures, processes, and policies related to quality control, testing, inspection, and other methods used to ensure the quality of products or services. This person may also be tasked with auditing various aspects of the Company’s operations to determine if they meet standards set by regulatory agencies or internal policies. This might include reviewing documentation, conducting interviews with employees, observing production processes, etc.

Duties & Responsibilities:

• Review environmental, personnel, and utility monitoring results and trends.
• Maintain inspection/site readiness.
• Provide support for audits of the site by regulatory agencies and other third-party auditors.
• Assist/conduct training for risk management, investigations, change controls, auditing, supplier management programs, and other processes as needed.
• Conduct audits of suppliers to ensure they comply with their procedures, regulations, and Polaris Pharmaceuticals, Inc. requirements.
• Provide QA & Compliance support for issues/concerns that arise within the site.
• Develop and maintain subject matter expertise in the risk assessment process.
• Develop familiarity and keep current with cGMP and applicable regulatory requirements as needed.
• Conduct internal audits of processes to ensure that they comply with site procedures and regulations.
• Develop and maintain subject matter expertise in root cause analysis for investigations.

Skills & Competencies

• Strong record keeping, organizational, written and verbal communication skills are essential.
• Must be able to oversee the completion of a project on time and within budget.
• Familiarity with use of a computer and Microsoft Office Suite (Windows, Word, Excel).
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Demonstrate strong leadership skills through past work history.
• Identify key issues in complex situations and analyzes problems and make sound decisions.
• Works independently as well as in a team environment.
• Excellent written, verbal, and communication skills.

Education & Experience

• 4-6 years of related work experience.
• B. S./B. A. in Science/Related Field (major in quality assurance-quality control-engineering).
• Experience with risk management facilitation is required.
• Ph.D. in Science/Related Field (major in quality assurance-quality control-engineering).
• Formal Risk Management training is recommended.
• MS Degree in Science/Related Field (major in quality assurance-quality control-engineering).
• Experience with cGMP environments and quality systems is required.