Quality Compliance Associate - Remote

Overview

The Quality Compliance Associate provides core compliance functions and project support for the Quality Compliance department including SOP document preparation and updates, training file maintenance, and compliance audits.

In Short

• Ensure SOPs and corresponding test assessments are created and updated according to internal policies.
• Support management of the Quality Management Systems (QMS).
• Assist with audit scheduling and logistics.
• Provide Regulatory/Client Audit Support.
• Manage Problem Notification Form (PNF) and CAPA data entry.
• Support the maintenance and archival of all QA records.
• Assist in department-related special projects.
• Provide administrative support for the Quality Assurance department.
• Work independently and within a team environment.
• Maintain confidentiality of sensitive information.

Requirements

• Bachelor’s degree or equivalent work experience.
• 1 – 2 years of relevant experience in a regulated pharmaceutical or medical device industry.
• Proficient in Microsoft Office Suite and SharePoint.
• Excellent written and oral communication skills.
• Strong organizational and time management skills.
• Ability to work independently and within a team.
• Attention to detail in composing and proofing materials.
• Experience with Standard Operating Procedures/policies preferred.
• Project support experience preferred.

Benefits

• Opportunity to work in a regulated industry.
• Gain experience in quality compliance and audit support.
• Collaborative work environment.
• Professional development opportunities.
• Flexible working conditions.