Quality Assurance Associate

This is a fully remote position, open to applicants in Kentucky, +1 more state.

📋 Description

• Support Auditors during Sponsor audits and inspections by regulatory authorities.

• Oversee and initiate regional assessments for the annual revision of the Business Continuity Plan.

• Aid in monitoring audit findings, deviations, and CAPAs identified during Quality Assurance Audits.

• Conduct quality control checks on Standard Operating Procedures (SOPs), including formatting and spelling verifications.

• Manage the distribution of company SOPs.

• Suggest and apply process enhancements to optimize the usage of the Learning Management System (LMS).

• Develop and format document templates and trackers.

• Maintain quality records in accordance with SOPs.

• Collaborate with Auditors to expand and refine Quality Assurance responsibilities.

• Assist with scheduling audits and tracking deliverables.

• Support QA Auditors during Vendor Audits, Internal System Audits, and the validation of Computerized Systems.

• Facilitate the coordination of Quality Management System (QMS) activities, including co-administration, quality control documentation review, and user acceptance testing documentation.

• Help in the creation of QMS procedures and work instructions/job aids.

• Aid QMS document owners/users with data entry into the QMS.

• Assist management in following up on deviations and CAPAs within the QMS.

• Support the completion of RFIs related to Quality Management Systems in region-specific international functions.

⛳️ Requirements

• Bachelor's Degree or an equivalent combination of education and experience.

• 0-1 years of relevant work experience.

• Basic comprehension of GxP Guidelines, particularly ICH/GCP Guidelines, and pertinent country-specific regulations.

• Outstanding verbal and written communication abilities.

🏝️ Benefits

• Structured mentoring program and leadership training courses.

• Tuition reimbursement.

• Dedicated training department.

• Comprehensive health benefits.

• Vacation packages.

• Hybrid work-from-home options.

• Paid parental leave.

• CTI Cares program.

• Support for work-life balance.