Quality Compliance Specialist (Change Controls)

Role Summary

Quality Compliance Specialist (Change Controls) focusing on internal change controls. Ensures quality and compliance to cGMPs, internal, external, and international requirements in change control activities. Mon-Fri, 8:00 a.m.–4:30 p.m. schedule.

Responsibilities

• Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Facilitating cross functional meetings and providing guidance and consultation to change control owners
• Developing relationships with end users and providing guidance on standard processes in Change Control
• Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures
• Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.
• Supporting regulatory and customer audits.

Qualifications

• Experience by level: Associate Quality Compliance Specialist – 0-2+ years; Quality Compliance Specialist – 2-5+ years; Senior Quality Compliance Specialist – 5+ years.
• May substitute proven experience for education requirement.
• Experience in change control function strongly preferred.
• Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships.
• Preferred: Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.

Skills

• Required: Proficient digital literacy in Microsoft Word, Excel and PowerPoint.
• Preferred: Experience with Veeva/QMS.

Education

• B.S. in Life Sciences, Engineering or related field.