Quality Control Analyst
About The Position
Responsible for supporting Meridian’s Quality Policy and operating procedures through taking an active role in the Incoming Materials and Finished Product Inspection processes, utilizing QC equipment and completing the appropriate paperwork in alignment with Good Documentation Practices. Support the maintenance and improvement of the Quality Management System through engaging in the Internal Audit program and the CAPA process. Support Magellan’s Document System by managing document changes and new document initiations with the supervision of senior Documentation staff members. A heavy emphasis on documentation and process controls in compliance with current Quality System Regulations and ISO standards is required.
Requirements
- Bachelor of Science Degree with 0-2 years of experience or demonstrated success within operational area with 2-4 years of related experience required.
- Understand principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485.
- Excellent working knowledge of CGMP, QSR, GLP, and ISO regulations.
- Proficient in Microsoft Word and Excel.
- Practical knowledge of gauge management and qualification
- Ability to conduct product or process quality investigations.
- Detail and process oriented.
Nice To Haves
- Extensive experience with Inspection and Specification procedures is preferred.
- Ability to interact in internal and external audits and act a role model for the QC department.
Responsibilities
- Responsible for technical inspection of incoming materials.
- Review qualification testing of materials, components and equipment in support of manufacturing operations.
- Assist in preparing for audits and documenting status of audits.
- Perform internal audits to ensure processes comply with company procedures, ISO 13485 and 21 CFR Part 820 requirements.
- Issue audit findings which identified procedural weaknesses or process deficiencies and provided recommendations for improvement.
- Perform root cause investigations to determine appropriate closure route for internal audit findings.
- Maintain CAPA progress charts to ensure CAPAs are addressed according to stated schedules and timelines.
- Support Quality KPI and Management review by tracking progress on QMS activities and ensuring production quality metrics are obtained and reviewed for presntation and documentation.
- Performed administrative review of Engineer Change Orders and input ECO documentation into the Electronic Quality Management System.
- Write and/or revise procedures related to quality assurance processes.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
