The Quality Assurance Specialist I is responsible for ensuring Acclinate’s products and services meet the highest quality and ethical standards while maintaining compliance with all legal and regulatory requirements.

QUALIFICATIONS:

• Bachelor’s degree in a relevant field (healthcare administration, etc.)
• At least 2 years of experience in a quality assurance role, preferably in the healthcare industry (e.g., HIPAA, FDA)
• Knowledge of regulatory requirements such as FDA regulations, ICH guidelines, and GCP standards.
• Strong understanding of quality management systems and methodologies.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Strong analytical and problem-solving skills.
• Proven ability to manage and prioritize multiple projects simultaneously.
• Experience with quality management software and tools.

• Assist in the assessment of adherence to quality assurance policies and procedures to ensure compliance with industry standards and regulations.
• Participate in internal audits, as needed, to identify areas of improvement.
• Collaborate with cross-functional teams to ensure quality standards are met throughout the product development lifecycle.
• Ensure documentation and records related to quality assurance activities are maintained and updated, as required.
• Participate in regulatory inspections and provide support during audits.
• Communicate effectively with internal and external stakeholders.
• Stay abreast of industry trends, regulatory changes, and emerging best practices in quality assurance.