Quality Systems Coordinator – Pelican Products Inc. – Plymouth, MN, USA
Pelican provides a very competitive compensation and benefits package with opportunities for personal and professional growth. Get in on the ground floor with Pelican during these very exciting times of rapid growth, new products and new markets! Specifics of the position and qualifications are listed below:
Primary duties and responsibilities
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.
- Compile and analyze process metrics for Key Performance Indicators (KPIs) through the creation and maintenance of logs/registers, spreadsheets, databases, or other IT applications
- 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
- Follows company policies and practices as outlined in Handbook and follow guidelines regarding safety as outline in the AWAIR, and other safety procedures in accordance to the job.
- Performs additional duties as assigned
- Associate’s Degree, Technical School certificate/diploma, or equivalent experience; Bachelor’s degree preferred.
- 2+ years’ experience in quality systems coordination, 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 practices required.
- Experience working with Electronic Document Management, Product Data Management (PDM), Product Lifecycle Management (PLM), or Enterprise Resource Planning (ERP) systems is highly desired.
- Must be familiar with engineering and manufacturing documentation, and Bills of Material (BOM’s).
- Familiarity with product packaging, labeling, and technical publications is highly desirable
- Certification in quality, configuration management, records management, or related areas is highly desirable.
- Must have exceptional computer proficiency, particularly with MS Office, Visio, and other typical business applications.
- Must be flexible, self-motivated, and able to multi-task in a fasted environment, operate well in a team setting and interact effectively and cooperatively with employees at all levels.
- Requires exceptional attention to detail and accuracy.
- Excellent written and verbal communication skills.
- Must be able to operate in a fast-paced organization and be able to manage multiple projects simultaneously.
- Must have the ability to complete assignments within the time frame specified by the Manager.
- Must be flexible regarding working hours and overtime. Must be able to work overtime on evenings and weekends, with or without advanced notice.