Quality Analyst
LSPedia is seeking a highly motivated and detail-oriented Senior Quality Analyst with the potential to grow into a Quality Manager role in the near future. This position is crucial in ensuring that our quality management processes are robust, efficient, and compliant with industry standards. The ideal candidate will have strong analytical skills, be process-driven, and possess the ability to think critically about current and future processes. They will play a key role in document management, supplier management, and both internal and external audits, while working cross-functionally to drive results and ensure quality standards are met across the organization.
Key Responsibilities:
Assist with the creation, review, and maintenance of quality-related documents, ensuring compliance with company policies and regulatory requirements.
Implement and maintain document control processes to ensure that all documents are up-to-date and accessible to relevant stakeholders.
Manage supplier quality performance by conducting supplier audits, risk assessments, and audit evaluations to ensure compliance with quality standards, and developing corrective actions as needed.
Maintain all supplier quality certifications to ensure they are up to date.
- Internal and External Audits:
Assist with the execution of internal quality audits to ensure compliance with internal standards and regulatory requirements.
Support external audits, including preparing documentation, facilitating audit processes, and conducting corrective actions based on audit findings.
Analyze current processes to identify areas for improvement and develop strategies to optimize quality management systems.
Work cross-functionally to conduct corrective actions and drive the implementation of process improvements and ensure that quality goals are met, and open issues are closed.
Assist with Computer System Validation (CSV) processes for each software release, ensuring adherence to FDA’s Code of Federal Regulation (CFR) 21 Part 11 requirements and maintaining stringent pharmaceutical compliance.
- Cross-Functional Collaboration:
Serve as a key quality representative in cross-functional teams, providing guidance on quality standards and ensuring that quality considerations are integrated into all projects.
Influence and drive cross-functional teams to take actions and achieve quality objectives, ensuring timely and effective results.
Minimum Requirements:
- Bachelor’s degree in Quality Management, Engineering, Sciences, or a related field.
- 5+ years of experience in quality assurance or quality management, preferably within a regulated industry or high-quality driven industry.
- Strong understanding of document management systems, supplier management, and audit processes.
- Demonstrated ability to lead internal and external audits.
- Exceptional attention to detail, with a process-driven mindset.
- Strong problem-solving skills and the ability to think critically about current and future processes.
- Excellent communication and interpersonal skills, with the ability to influence and collaborate with cross-functional teams.
- Proven track record of being goal-oriented and results-driven, with the ability to manage multiple projects and deliverables simultaneously.
Preferred Requirements:
- Experience in a leadership or managerial role, with the potential to grow into a Quality Manager position.
- Advanced certifications in quality management (e.g., ASQ Certified Quality Auditor, Six Sigma).
- Experience in a SaaS or technology-driven environment.
- Familiarity with regulatory standards such as ISO 9001, FDA regulations, or equivalent.
- Experience in developing and implementing process improvements that have led to measurable quality enhancements.
- Strong project management skills and experience with quality management software tools.
About LSPedia:
LSPedia provides SaaS solutions to the pharmaceutical industry. Manufacturers, wholesale distributors, dispensers, and healthcare providers partner with LSPediA to make, move, track, verify, and protect the drug products in their care for patient safety.
LSPedia is different because our solution potential is limitless. Built with user efficiency, automation, and data security at their core, our solutions are transforming compliance and supply chain efforts. LSPedia’s OneScan™ and Investigator™ technologies enable error-free and keyboard-free capabilities for ASN, EPCIS, VRS, issue tracking, and interoperability.
