Quality Specialist

We are seeking a Quality Specialist to support controlled documentation activities, change governance processes, and quality system operations for a growing organization operating within a regulated manufacturing environment.This role will serve as a central resource across quality operations, documentation management, and compliance-related initiatives, helping ensure alignment between internal procedures, product requirements, and regulatory expectations. The position will support change control workflows, document revisions, quality records administration, validation coordination, and cross-functional process improvement efforts while partnering closely with manufacturing, quality, engineering, and operational teams.Requirements for the Quality Specialist:Bachelor’s degree in life sciences, engineering, quality, operations, or a related technical discipline.Several years (3+) of experience supporting quality systems, document control, compliance, or regulated operational functions.Working knowledge of regulated quality environments, including cGMP, FDA, and ISO 13485.Experience supporting controlled documentation processes, including revisions, approvals, training records, and document lifecycle management.Familiarity with change management systems, electronic quality systems, and validation documentation practices.Strong organizational and coordination skills with the ability to manage multiple projects, timelines, and quality records simultaneously.Ability to communicate effectively across technical and non-technical teams.Experience supporting audits, inspections, or compliance readiness activities is preferred.Comfortable operating within a fast-paced, cross-functional manufacturing or operational setting.Experience with ERP, PLM, LMS, or electronic document management systems is highly preferred.Responsibilities of the Quality Specialist:Coordinate and maintain controlled documentation activities, including SOP revisions, specification updates, training assignments, and archival support.Administer change management workflows including routing, tracking, meeting coordination, follow-up activities, and documentation review.Support cross-functional review processes related to product, packaging, labeling, and operational changes.Assist with the preparation, review, and organization of validation-related documentation, including protocols, reports, and execution records.Maintain quality system records and ensure the accuracy, completeness, and compliance of documentation with internal procedures.Partner with quality, operations, engineering, procurement, and external partners to support the implementation of process or product changes.Support audit readiness initiatives by organizing records, compiling documentation, and assisting with inspection preparation activities.Track quality system metrics, project milestones, action items, and compliance-related deliverables.Contribute to continuous improvement initiatives focused on process consistency, procedural alignment, and documentation efficiency.Assist with investigation support activities, data gathering, and follow-up coordination related to quality events or operational deviations.Occupational Category: 13-1199 Business Operations Specialists, All Other