Quality Assurance Specialist
1 month ago
Responsibilities
- Familiarity and proficiency in performing all responsibilities of the Quality Associate.
- Subject Matter Expertise in one or more specific Quality processes such as incoming inspection, change management, or records management. Also supports record administration and batch record review, including Certificate of Analysis/Conformance creation for material lot release.
- Assigns labeling and pre-production change requests to Change Management staff, aligning experience with project load and complexity. Processes IUO and IVD product labeling and associated RMS change requests while ensuring compliance with company policies and procedures. Capable of navigating complexity and troubleshooting issues with the most complex changes.
- Assists labeling change owners and junior staff with the creation of design change plans. Leverages subject matter expertise to impart positive impacts on organizational outcomes.
- Supports change packets per approved procedures, including analysis for impact to Device Master Records and associated maintenance of the DMRs. Independently corrects issues and proactively identifies future concerns. Leverages expertise to improve future submissions via collaboration with change owners.
- Creates and maintains Design History Files per approved procedures. Reviews records for good DHF documentation practices and adherence to DHF Document Change Control requirements. Maintains the Master Action Item List, DHF Index, and DHF History Index.
- Assists in the documentation of key processes and departmental procedures and participates in continuous improvement projects as assigned.
- Compiles and maintains data used for the creation of department metrics and reports. Capable of owning key local reporting responsibility and taking the lead in areas of expertise, as appropriate.
- Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
Requirements
- BS degree ( Engineering, chemistry, life sciences, etc.) or 3-7 years equivalent experience
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