Title: Quality Associate Job Type: Full time Location: Durham, NC 27703 Summary: Under the direction of the Quality Manager, the Quality Associate is responsible for ensuring process, material, and assembly compliance to customer specifications, ISO 9001, cGMP, and Carolina Components Group standards. The individual is responsible for understanding and effectively/compliantly operating, maintaining, and assisting management with selected aspects of the quality management program. Essential Duties and Responsibilities: Responsible for accurately and completely processing assigned Orders through the Quality Department prior to shipment to customers per applicable procedures, work instructions, and sales order folder contents. Responsible for performing and documenting First and Final Article Inspection activities as required for internally built custom assemblies. Responsible for maintaining daily work schedule in coordination with Operations, Sales, and Manufacturing personnel; Responsible for performing incoming material inspection, labeling, and release for placement into inventory and/or quarantine locations. Responsible for working with Inventory Management to stage material for inspection in a manner designed to prevent mixing of unreleased and released products. Responsible for working with Inventory Management to ensure that inventory locations are accurately labeled and that unreleased and released products are clearly identified and segregated. Responsible for reviewing and approving logbooks and forms to comply with procedure. Responsible for working with employees and vendors to clarify or correct issues impacting order completion, including issuance of vendor-product certificates and support documentation. Responsible for attending meetings as a representative of the Quality Department and providing meeting details to the department as required. Responsible for initiating, assisting, & completing documentation and escalation of Supplier Corrective Actions, Non-Conforming Events, and Corrective Actions Preventive Actions. Interface with customer and vendor quality personnel as needed. Responsible for working with Cross-Functional teams to ensure on-time completion of scheduled Calibration and Preventive Maintenance activities; creating, reviewing, and filing Calibration and Equipment History records as needed. Inclusive of out of specification results? Responsible for reviewing and approving engineering production drawings. Responsible for setting up Quality Control Plans, Tests, and Attributes for specific parts. Responsible for performing scheduled Internal Quality Audits Responsible for generating supporting regulatory documentation as requested by customers and as required for Pre-enrollment Packages. Assist in development and improvement of internal processes to achieve standardization. Inclusive of drafting, revising, and reviewing system documentation. Responsible for working with Operations and Manufacturing to refine and improve compliance standards for order processing. Identifying and implementing Quality continual improvement initiatives. Conduct training initiatives within Quality Department and with other CCG employees as needed. Inclusive of training new hires within the Quality Department. Rotate between business locations to ensure coverage, understanding of roles, and cross-functional requirements. Responsible for other activities as requested. Desired Education: Bachelor's degree Desired Experience: 3-5 Years Quality Assurance Experience or 3-5 Years Pharmaceutical/Biotech Manufacturing experience ERP experience a plus (Acumatica) Electronic Quality Management System (eQMS) experience a plus (Qualio) Strong computer skills including Microsoft Office Strong Organizational skills Effective communication skills
