The Quality Systems Coordinator position will provide support in 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.
What You'll Do:
- Support the processing and evaluation of all documentation revision requests, including making decisions on whether requests are complete and sufficient to achieve the intended documentation revisions.
- Manage retention of records required to demonstrate quality system conformance.
- Evaluate and assure documents and records conform to established Good Documentation Practices and Document Control compliance.
- Review documents for completeness and accuracy; ensure compliance with established processes and standards.
- Generate Certificates of Conformance for customer shipments.
- Provide support regarding Label Management (labeling creation, distribution, troubleshooting support for third parties and company sites, etc.).
- Support the Training Management System for Quality, managing training records, and coordinating training of third parties and company sites.
- Support in compilation and analyzing process metrics for Key Performance Indicators (KPIs) through the creation and maintenance of logs/registers, spreadsheets, databases, or other IT applications.
- Support and guide the Process Deviation Request process.
- Monitor status of action plans arising from processes including internal audit, CAPA, Management Review, Deviations, and Change Management.
- Monitor 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.
- Provide guidance and back-up to quality inspectors to ensure products and processes comply with quality management system requirements.
- When needed, assist with the Nonconforming Product process to ensure data integrity and process compliance and effectiveness.
- When needed, assist with the CAPA process to ensure appropriate root cause analysis, timely progress, and corrective action planning, verification, and validation.
- Follow 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.
- Perform additional duties as assigned.
What You'll Need
- Associate’s degree, technical school certificate/diploma, or equivalent experience.
- 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 programs, Visio, Adobe, and other typical business applications.
- Requires exceptional attention to detail and accuracy.
- Excellent written and verbal communication skills.
- Bachelor’s degree.
- Experience to facilitate training sessions.
Must be flexible, self-motivated, and able to multi-task in a fast-paced environment, operate well in a team setting, and interact effectively and cooperatively with employees at all levels.
Must have the ability to complete assignments within the timeframe specified by the Manager.
Must be able to operate in a fast-paced environment and handle multiple projects simultaneously.
PHYSICAL REQUIREMENTS AND WORKING CONDITIONS
While performing the duties of this job, the employee will be frequently required to execute standard physical activities within the facility areas (i.e. stand, walk, sit, use hands/fingers).
While performing the duties of this job, the employee will be occasionally required to executive non-standard physical activities within the facility areas (i.e. climb or balance, stoop, kneel, crouch).
Ability to lift and/or move up to 10 pounds and occasionally lift and/or move up to 40 pounds.
This position requires repetitive hand/wrist activities.
Pelican Products, Inc. is an Equal Employment Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Total Quality Management
Provide Technical Guidance