The Senior Quality Specialist is responsible for ensuring the effective execution of core Quality Management System (QMS) processes, including Document Control, Records Management, and Training, required for quality and manufacturing regulatory compliance.
Principal Duties and Responsibilities
Manage all regulatory records, including documentation, policies, procedures and systems, including the Quality Management System (QMS), quality-related training requirements and records.
Lead internal compliance reviews of records, documentation and systems; initiate, complete, certify, and document compliance and/or appropriate remedial action.
Manage Document Change Orders (DCOs), including reviewing and processing DCOs, performing cross references, logging approvals; primary point of contact for change orders.
Manage and maintain records controls and procedures; including access to records, storage of electronic records, and establish on-site and off-site storage and retrieval of hard copy records.
Coordinate Management Review process by planning and managing associated inputs and outputs.
Support internal audits and 3rd party agency audits, ensure timely and effective resolution of issues identified.
Identify and recommend QMS processes and procedural improvements.
Complete work assignments independently or with minimal supervision.
Oversee the issuance and maintenance of lab notebooks.
Guide cross-functional teams in Good Documentation Practices.
Monitor external standards as assigned.
Other duties as assigned
Experience requirements
Minimum 4 years of quality-specific documentation experience.
Experience in an FDA-regulated environment strongly preferred.
Experience with ISO 13485 and FDA 21 CFR 820 strongly preferred.
Understanding of Quality System, Good Manufacturing Practices, and Good Documentation Practices.
Familiarity with electronic document control systems.
Experience with word processing, spreadsheet and presentation software.
Education Requirements
Undergraduate degree in a quality related field, or equivalent experience.
Other qualifications
Strong computer skills, including ability to work effectively with Microsoft Office.
Acute attention to detail. Excellent written and verbal communication, and time management skills required.
Must have a positive attitude with strong interpersonal communication skills.
