Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR's, global import/export regulations, etc.
- New product setup and management of related projects.
- Assist with Supplier audits, as needed Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
- Serve as a resource for customer's regulatory and technical inquiries Ongoing maintenance of ISO 13485 based quality system.
- Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution.
- Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
- Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.
- Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
- Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.
- Assists in representing in customer quality audits, supplier quality audits and regulatory inspections.
- Performs investigations and analysis activities to support resolution of quality issues.
- Collaborates with organizational teams to support quality system implementation.
- Creation of new product master files satisfying customer and quality system requirements.
- Ensures quality standards by following company & departmental policies & procedures including, but not limited to.
- Product performance & quality verification.
- Identifying, recording, and investigating problems related to product, process & quality systems.
- Evaluating processes for improvements and standardization.
- Initiating action to prevent non-conformance in products, process, and quality systems.
- Training on quality systems and applicable regulations as identified by supervisor and required by position.
- Tracking/trending aspects of the QMS.
- Other job duties as required.
Requirements:
- Minimum of Bachelor's degree in Science, Engineering, Bioengineering or related field. Prefer Chemistry or Biology degree programs.
- Preferred Education, Years and Area of Experience:
- Minimum 3 years' experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry.
- Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485.
- Ability to develop, update and train on SOPs.
- Working knowledge of ISO standards and Quality Management Systems (QMS).
- Problem solving techniques to perform investigations and drive root cause analysis.
- Related work experience performing internal/external audits.
- Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products.
- Experience with Continuous Improvement, Lean or Six Sigma.
- SAP, EtQ and/or PeopleSoft experience.
- Experience with statistical analysis.
- Project management experience.
- Animal by-product import/export regulations.
- Animal health and/or virology, immunology, epidemiology knowledge.
- Ability to multi-task with ability to be organized.
- Strong interpersonal and communication skills.
- Strong time management skills and attention to detail.
- Ability to influence others in a team environment while collaborating with peers and functional areas.
- Ability to work independently with minimal supervision.