The Quality Systems Specialist is responsible for supporting and maintaining the Quality Management System (QMS) within a regulated pharmaceutical, biotechnology, medical device, or life sciences environment. The role ensures compliance with applicable GxP, GMP, FDA, and ISO requirements by managing quality system processes, documentation, deviations, CAPAs, change controls, training records, audits, and continuous improvement activities. The specialist works cross-functionally with Quality, Manufacturing, Engineering, Regulatory, Validation, and other business teams to maintain a compliant, inspection-ready quality system.
- Bachelor's degree in Quality, Engineering, Life Sciences, Chemistry, Biology, Pharmacy, or a related field.
- Typically 3-5+ years of experience in Quality Systems, Quality Assurance, or a related regulated-industry function.
- Experience working in pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
- Strong knowledge of GMP/GxP, FDA regulations, and Quality Management Systems.
- Experience with CAPA, deviations, change control, document control, and investigations.
- Familiarity with electronic QMS platforms such as Veeva QMS, TrackWise, MasterControl, or equivalent.
- Strong understanding of data integrity and Good Documentation Practices (GDP).
- Experience supporting audits, inspections, and quality system remediation.
- Excellent analytical, organizational, documentation, and communication skills.
- Ability to work independently and collaborate effectively with cross-functional teams.
- Quality Systems Specialist\Master Data Analyst with strong SAP experience to support enterprise master data governance across manufacturing, supply chain, engineering, and quality organizations.
- This role is responsible for creating, maintaining, and governing master data to ensure accuracy, compliance, and operational efficiency throughout the product lifecycle.
- The ideal candidate has strong SAP technical expertise and a passion for data quality.
- They are proactive, collaborative, and comfortable working across multiple functions to ensure master data accurately supports production, engineering changes, and business operations.
- This individual thrives in a fast-paced environment and consistently seeks opportunities to improve processes, reduce manual effort, and enhance data integrity
- Must have a Bachelor's Degree
- Medical Device experience is ideal, but will consider other Regulated Industry experience