Under minimal supervision, the Quality Assurance Specialist II will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, NCMRs, Change Controls, Process Improvements, and execute Root Cause Analysis. Candidates will participate in both internal (annual, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits. Candidates will maintain the Controlled Document System and all associated tasks necessary to keep this system functional, current, and compliant.
Essential Duties/Responsibilities:
- Participate in all aspects of Quality Assurance to ensure sterilization activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
- Participate in the internal auditing program to ensure the established techniques are followed and understood.
- Participate in the planning, preparation, and hosting of customer, regulatory, and accreditation audits; respond to audit reports and implement resolution of audit findings; complete Supplier assessment evaluations.
- Maintain and control site-specific procedures including Standard Operating Procedures, Protocols, Forms, NCMRs, CAPAs, Deviations, Complaints/Inquiries, Change Orders, quality data sheets/records, calibration records, training records and logs.
- Manage and control the Document System in compliance with the FDA regulations, ISO 13485:2016 guidelines, and company policies.
- Review Work Order forms.
- Audit various reports prior to issuance (e.g. validation reports, audit reports, etc.). Serve as site contact for quality inquiries on reports and related documentation.
- Create, revise, review, and approve newly written documents and document revisions.
- Work with Operations Management to maintain the training program and ensure that operations personnel have completed all necessary training requirements.
- Train site personnel in GXP/ISO procedures, practices, and guidelines.
- Maintain Customer validation report logs and requalification due dates
- Initiate and process DCOs, NCMRs and CAPAs and participate in related investigations and document findings with data
- Assist management in preparing for the Management Review process.
- Assist management in ensuring all licenses remain current (e.g. ISO, FDA, City, etc.)
- Collect, track, and analyze quality metrics (OOS, NCMRs, CAPAs, complaints, etc.) and train
laboratory personnel, as needed to help reduce quality events. - Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings.
- Assist senior leadership in maintaining the list of approved suppliers and subcontractors.
- Exist as a backup for other Quality Assurance personnel.
- Other duties as assigned by departmental management.