Overview
Supplier Quality Engineer (Supplier Change Notification/CAPA/Investigation) Jobs in Barceloneta, PR at Systems Ally
The Quality Associate contributes to meeting Langham goals of exceptional Client service, quality, process improvement, and profitability by performing the following tasks:
ensuring accurate shipping and receiving by performing QC checks on all incoming and outgoing materials;
uploading Temperature Recording Device (TRD) data and handling TRDs according to procedure;
ensuring compliance with regulatory standards by performing audits according to the audit schedule;
ensuring accurate inventory management by reviewing and approving all material adjustments (including disposition changes);
initiating and overseeing quality records within the QT9 electronic QMS, including but not limited to, Deviations, Nonconforming Products, Corrective Actions, Preventive Actions, Audits, Change Control, Risk Assessments, Supplier Evaluation and Qualification and Customer Feedback;
monitoring CAPAs for effectiveness;
ensuring all staff have completed properly documented training in QT9, and maintaining employee files;
assisting the Quality Manager with formal inspection/audit responses;
assisting the Quality Manager with facility license applications and renewals;
gathering and trending quality data;
ensuring proper Client communication as it relates to Quality issues according to the SOPs and/or the Client Quality Agreement.
Key Outcomes Expected
The Quality Associate is expected to:
Work according to Langham Logistics policies and procedures;
Meet established quality and productivity metrics;
Keep work areas neat and clean;
Accept or reject material based on quality/regulatory standards and Client requirements;
Physically check all incoming and outgoing materials for damage and other discrepancies;
Identify and report discrepancies between paperwork/orders and physical product delivered;
Initiate and oversee quality records in QT9;
Provide courteous, professional service to both internal and external Clients;
Present a positive image Langham.
Critical Skills, Knowledge, and Behaviors
Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
Teamwork – ability to establish professional relationships and rapport with internal and external peers and management.
Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
Organization – ability to manage multiple quality records with various due dates to ensure timely completion and maintain records in a readily retrievable format.
Education and Experience
High school diploma or GED required.
1-2 years’ experience in Quality Control or related field within a GMP facility
Forklift experience a PLUS
Work Environment
Work is performed in a warehouse/office/external environment with multiple zones of varying temperature: frozen, refrigerated, controlled room temperature, and environmental.
Benefits
401k, Dental Insurance, Life Insurance, Medical Insurance, Vision
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Title: Supplier Quality Engineer (Supplier Change Notification/CAPA/Investigation)
Company: Systems Ally
Location: Barceloneta, PR
