Associate Quality Systems Specialist

• Experience with Change Control / Change Order processing in a regulated environment.
• Experience performing document impact assessments and where-used reviews.
• Experience with Quality Systems, Document Control, or eQMS processes (Like Agile MAP) within Medical Device, Pharmaceutical, Biotechnology, or other regulated industries.

Years' Experience

Required:

2 years of relevant experience preferred but flexible based on relevant experience

Description:

The Associate Quality Systems Specialist supports site closure activities by processing change orders, executing where-used assessments, coordinating documentation updates, and ensuring timely implementation of quality system changes in compliance with company procedures and regulatory requirements.

• Process change orders associated with site closure and quality system inactivation activities.
• Execute where-used assessments to identify impacted procedures, forms, specifications, records, and quality system documents.
• Coordinate document updates and obsolescence activities required for site closure.
• Support impact assessments and implementation of approved changes.
• Track change order progress and ensure completion within established timelines.
• Collaborate with cross-functional stakeholders including Quality, Operations, Engineering, Regulatory Affairs, and Document Control.
• Maintain accurate records within the electronic Quality Management System (eQMS).
• Support project reporting and status updates for site closure activities.
• Ensure compliance with internal quality system requirements and applicable regulations.

• Strong attention to detail.
• Excellent organizational and time management skills.
• Ability to manage multiple assignments and meet deadlines.
• Strong written and verbal communication skills.
• Proficient in Microsoft Office applications.
• Ability to analyze information and identify document impacts across quality systems.
• Ability to work independently and collaboratively within cross-functional teams.

• Internship, co-op, or academic project experience in Quality, Manufacturing, Engineering, Regulatory Affairs, or Document Control.
• Experience working in a regulated environment such as Medical Device, Pharmaceutical, Biotechnology, or Manufacturing.
• Familiarity with quality systems and document control processes.
• Experience with electronic quality management systems (eQMS) is a plus.