Quality Assurance Specialist II
Quality Assurance Specialist II
Under limited supervision and with a solid understanding of science and technology, monitors operations and develops and manages quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s North American operations.
Support the organization in monitoring of the compliance of laboratory testing, manufacturing, and clinical research and ensuring continued effectiveness of the QMS according to FDA, CLIA, CAP, HIPAA, GCP, GLP, GDP, and QSR requirements
- Prepare, maintain, analyze, and present metrics related to the quality systems
- Conduct and/or support internal audits, client audits, supplier audits, and regulatory audits including, but not limited to: audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up
- Work to accomplish efficient and effective to perform quality review/audit of: certificates, procedures, protocols, risk assessments, reports, IQ/OQ/PQ documents, validations, deviations, complaints, and non-conformances/CAPAs, or other quality records, and provide professional and objective feedback based on the results
- Communicate effectively with internal personnel, external customers, and suppliers
- Collaborate effectively and positively within department and all other company departments
- Non-conformance and CAPA: Manages the tracking, trouble shooting, investigation and progression of corrective and preventive actions related to non-conforming product or deviations from approved processes.
- Complaints: Manage the logging and investigation of customer complaints and feedback to the sales team.
- Change Control: Review, provide quality insight and approve and/or support change control process for procedures, methods, equipment, and computer systems.
- Document Control: Facilitate process for new, revised, and obsoleted documents (policies, procedures, forms, templates, marketing materials, etc.) and ensure proper tracking for status.
- Training: Conduct and/or support continuous quality training including, but not limited to: induction/orientation, ongoing quality training, and annual regulatory training requirements.
- Incoming Quality Control: Assist in conducting inspections of raw materials for manufacturing and laboratory testing reagents and consumables.
- Equipment: Ensure that equipment maintenance and servicing is performed according to specifications and that all equipment is qualified for use appropriately.
- Process Validation: Support validation of laboratory procedures, collect and analyze data, and perform routine document review and special audits.
- System Validation: support validation of software and system testing.
- Reporting: Organises reports and interdepartmental meetings as required.
- Bachelor's degree in a life science
- 5+ years Quality experience in a laboratory setting strongly preferred
- Medical device experience a plus
- Experienced in working to CAP/CLIA/GCP/GLP and Quality Management principles
- Strong attention to detail and Quality commitment
- Good working knowledge of MS programs
- High standards of mathematics and writing ability