Quality Assurance Specialist I

Fujifilm•New Castle, DE

2d•Onsite

About The Position

The Quality Assurance Specialist I is responsible for executing and supporting the routine QA systems at the Fujifilm New Castle site. This role ensures that all routine products consistently meet established business quality standards. The incumbent will manage documentation related to Controlled Documents, Management of Change (MOC), Training Records, Audits, and Sample Shipping. Additionally, the specialist will identify and escalate non-routine or non-compliance issues to the appropriate functional leads, maintaining strict adherence to quality protocols. Reporting directly to the Quality Assurance Supervisor, this role supports all QA requirements across the New Castle production site. Key tasks include daily batch clearance of routine production products, conducting internal and external audits, responding to routine customer complaints, and identifying opportunities to enhance current QA systems. The Quality Assurance Specialist I will maintain comprehensive documentation for Quality Systems, identify system gaps or inefficiencies, and liaise cross-functionally with departments such as Supply Chain, Production Support, Quality Control, Operations, Engineering, customers, and suppliers. Non-compliance matters or issues beyond routine scope will be escalated seamlessly to the QA Supervisor for resolution.

Requirements

Minimum High School Diploma with 3–5 years’ experience in quality assurance or relevant manufacturing environments.
Strong interpersonal and communication skills.
Highly organized with exceptional attention to detail.
Ability to work independently and manage multiple priorities efficiently.
Strong problem identification and escalation abilities.
Proven data management capabilities.
Proficiency with MS Office (Word, Excel, PowerPoint), LIMS, SAP, and the aptitude to rapidly learn new software applications.
Basic analytical and problem-solving skills.

Responsibilities

Execute routine batch clearance of base materials and finished products.
Review internal QC and manufacturing process results for compliance against specification and following the approved batch clearance process.
Ensure all QC and QA documentation is complete and auditable.
Ensure all manufacturing paperwork is reviewed for legibility, completeness, and filed properly for final products.
Perform routine physical inspection of finished goods prior to release.
Review the control limits for final products and specifications of base material and final products and relay any issues to the QA Supervisor.
Identify materials requiring formal batch review.
Administer deviations of finished goods when necessary and progress with appropriate personnel (manufacturing, technical, QC, etc.) through to completion.
Progress all non-conforming, questionable or non-routine issues to the QA Supervisor.
Monitors non-RFT finished goods and documents appropriately.
Manage the updating of QA status into SAP inventory records, generate and issue COA’s, and arrange pre-shipment samples and shipping documentation as appropriate.
Participate in internal and external audits.
Support the MOC process by performing actions as assigned, maintaining records, and updating MOC documentation with batch status.
Act as the administrator for document control and training systems.
Review and update QA procedures and work instructions as they relate to routine production and business needs.
Evaluate existing systems and streamlining where appropriate, while ensuring that quality system requirements are met.
Identify opportunities for improvement of the QA systems and provide options and recommendations to resolve problems and issues resulting from QA investigations and audits.