Systems Coordinator

2 weeks ago


Bedford, United Kingdom Pelican Products, Inc. Full time

Systems Coordinator

**Date**:Nov 29, 2023

**LOCATION**: Bedford, BDF, GB

**Company**:Pelican Products, Inc.

Manages the collection, monitoring, and distribution of quality system documented information to facilitate the effectiveness, efficiency, and continuous improvement of the quality system, including compliance to external standards, customer requirements, and internal policies through a combination of administration, coordination, guidance, enforcement, and direct participation of/in quality system processes.

**Control of Documented Information (60%)**
- Manage the processing and evaluation of all documentation change requests; including making decisions on whether requests are complete and sufficient to achieve the intended change objectives
- Provide guidance and assistance to change requestors in updating documents, creating or updating Bills of Materials, and submitting change requests
- Manage retention of records required to demonstrate quality system conformance
- Evaluate and assure documents and records conform to established Good Documentation Practices
- Assemble and review documents for completeness and accuracy, and distribute to stakeholders
- Generate Certificates of Conformance for customer shipments
- Provide support regarding Label Management (labeling creation, distribution, troubleshooting support for third parties and company sites, etc.)

**Quality System Management (40%)**
- Oversee the Training Management System, including creation of training matrices for employees, monitoring training compliance, managing training records, and coordinating training of third parties and company sites.
- Monitor status of action plans arising from processes including internal audit, CAPA, Management Review, Deviations, and Change Management.
- Monitors the calibration management system to ensure timely re-calibration of measuring equipment.
- Develop and maintain databases, logs, and/or other tools for effective management of required records and information

**General duties**
- Assists in providing all necessary info for ISO auditors
- Actively supports Peli’s Quality Objectives and contributes to Quality Management System activities as assigned.
- Performs other duties and work on special projects as required or assigned by the Quality Manager

**QUALIFICATION GUIDELINES**
- Bachelor’s degree/HNC/HND in science or engineering or 2+ years’ experience in quality systems coordination,
- Certification in quality, configuration management, records management, or related areas required
- Experience in a manufacturing or packaging environment, preferably in an ISO 9001 certified and/or life-science regulated environment (pharmaceutical, biologics, or medical device).
- Knowledge of one or more Document Control, CAPA, Audit, Nonconforming Product, Inspection, or other quality system process required.
- Good **Knowledge and experience of SAP or similar ERP desired.**
- Familiarity with product packaging, labeling, and technical publications
- Must be proficient with word, excel, engineering and manufacturing documentation, and Bills of Material (BOM’s).
- Excellent analytical, organizational and negotiation skills. Must be able to operate in a fast-paced organization and handle multiple projects simultaneously within set timeframes.
- Must have excellent verbal, written, maths and presentation skills, with great attention to detail.
- Must be able to interact effectively and diplomatically with all company personnel under minimum supervision and be responsive to the requirements of department members and other departments with whom interaction is necessary.
- Must be flexible regarding working hours and overtime. Must be able to work overtime on evenings and weekends, with or without advanced notice.
- Must be able to travel to visit customers, suppliers, subcontractors or other Peli/Pelican sites as and when necessary.

**Job Segment**:Quality Manager, SAP, ERP, Inspector, Quality, Technology



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