Quality Systems Specialist I

The Quality Systems Specialist I performs moderately complex Quality Systems activities and supports the timely progression of QMS records and improvement initiatives. This role works closely with process owners and cross-functional stakeholders to ensure records are complete, compliant, and effectively resolved. The position is expected to support assigned priorities with limited supervision, identify issues requiring escalation, and contribute to team training and process improvement.

Responsibilities

Support assigned deviations, investigations, CAPAs, change controls, quality events, document revisions, and related QMS activities under supervision of management and peers; Review quality records for completeness, accuracy, procedural compliance, and appropriate supporting evidence; Coordinate with Manufacturing, Quality Control, Validation, Engineering, and other functions to obtain information and progress records; Support root-cause analysis, risk assessments, corrective-action development, and effectiveness verification; Track assigned records against established timelines and escalate delays, risks, or resource constraints; Support Quality KPI data collection, verification, reconciliation, and routine trend reporting; Identify recurring issues or process inefficiencies and recommend practical improvements; Support audit and inspection readiness, including document retrieval, record review, and response preparation; Serve as a knowledgeable resource for assigned QMS processes; Provide training or day-to-day guidance to Quality Systems Specialist I personnel and process owners; Participate in continuous improvement projects and implementation of revised procedures or systems; Maintain accurate and inspection-ready documentation

Requirements

High School diploma or equivalent required; 1-3 or more years of experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or a related regulated industry; Demonstrated knowledge of GMP regulations and quality-system requirements, including applicable FDA, EU, and international regulatory expectations; Experience managing or supporting deviations, investigations, CAPAs, change controls, document control, training, audits, inspections, and quality metrics; Demonstrated experience interacting with clients, regulatory agencies, and internal or external auditors; Strong analytical, organizational, problem-solving, and decision-making skills; Ability to support multiple priorities in a fast-paced, complex manufacturing environment; Strong written, verbal, presentation, and stakeholder-management skills

Nice to have

Bachelor's degree in Life Sciences or a related field preferred; Experience supporting sterile, biologic, pharmaceutical, or contract manufacturing operations preferred; Proficiency with electronic quality management systems and quality-data reporting tools preferred

Benefits

paid time off; health insurance coverage (including dental and vision); flexible spending account; 401(k) plan; eligibility for an annual performance bonus