Quality Assurance Specialist

Job Description

Job Description

About ITS Logistics

Are you ready to unleash your potential and be a part of one of the fastest growing, exciting, logistics companies in the US?

ITS Logistics is a premier Third-Party Logistics company that provides creative supply chain solutions. With the highest level of service, unmatched industry experience and work ethic, and a laser focus on innovation and technology our purpose is to improve the quality of life by delivering excellence in everything we do.

At ITS, we invest in your personal and professional growth, providing the tools, resources, and support you need to unleash your full potential, collaborate with like-minded teammates, and seize limitless opportunities.

By joining our all-star team, you will be part of an organization that values your unique skills, encourages your drive for excellence, and recognizes your unwavering commitment to achieving our shared goals.

We empower our team members to become champions in their respective fields by nurturing a culture of collaboration, competition, and unyielding resilience.

We believe that together, we can conquer any challenge and achieve remarkable victories.

Want to learn more about ITS Logistics? Check out our website! www.its4logistics.com

About the Position

The Quality Assurance (QA) Specialist is responsible for quality oversight of business areas which require adherence to current good manufacturing practices.

• Develop, implement, and maintain quality management systems in accordance with 21 CFR 820 and ISO 13485 requirements.
• QA oversight for equipment, utilities, and facilities.
• Conduct internal audits to assess compliance with quality management systems and regulatory requirements.
• Collaborate with internal, external auditors and regulatory agencies during audits and inspections.
• Investigate nonconformities and implement corrective and preventive actions to address root cause and prevent recurrence.
• Review and approve documentation, including control records, validation protocols, and change management.
• Facilitate the completion of Risk Analysis documentation for new and existing process
• Provide cGMP and controlled document training for new hirers and refresher training annually for all warehouse departments.
• Maintain the professional competence, knowledge, and skill necessary for satisfactory performance of all assigned responsibilities.
• Perform other assigned duties as necessary within the realm of the Quality department.
• Work independently in an on-site role.

About the Requirements

• Bachelor's degree in engineering, life science, or related field preferred not required.
• Possess knowledge and hands-on experience with ISO quality system standard : ISO 13485, and FDA 21 CFR 820.
• Ability to work effectively with various work groups to assure conformance to quality and regulatory requirements internal processes and policies.
• Ability to prioritize tasks in deadline driven environment.
• Experience leading risk management activities, including risk assessment and risk mitigation strategies.
• Strong written and verbal communication and organizational skills.
• PC Skills Word, Excel, PowerPoint, & Outlook

Compensation

Salary Range : 65,000 - 85,000 (DOE) with a performance based bonus structure. We offer a comprehensive multi-tiered benefits plan, paid time off and a matching 401k are included.