Quality Specialist

Role Summary

Quality Specialist

Responsibilities

• Interpret drawings and specification documents.
• Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence.
• Determine inspection sample size based on procedures, specifications, and standards.
• Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence.
• Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices.
• Approve/perform final disposition of materials/components/subassemblies/finished products.
• Assign and apply expiration dating labels to materials/parts/products, as per the specifications/quality procedures.
• Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s). Work with NCMR and deviation owners to ensure action plans are completed in a timely manner.
• Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
• Maintain accurate records as per Document Control procedures.
• Coordinate IQC priorities and monitor IQC tasks and deliverables.
• Support training of IQC personnel.
• Handling and shipping of samples to external testing laboratories.
• Assist in the coordination of equipment preventative maintenance and calibration and maintaining equipment files.
• Assist with performing environmental monitoring of Controlled Environment Rooms (CERs).
• Review and update Standard Operating Procedures (SOPs) to ensure compliance with the QMS.
• Support Quality in the collection of quality metrics data and data monitoring.
• Assist QA during quality audits.
• Interact closely with different functions of the organization.
• Performs other duties as needed to support the Quality Assurance Department and the company.

Qualifications

• Minimum of 5-6 years of related work experience, especially performing inspections and reviews/approvals of manufacturing batch records/inspection records.
• Government Regulated Environment experience such as FDA and ISO 13485
• Must have adequate computer experience (knowledge of Microsoft Word, Excel)
• Experience working in a cGMP environment

Skills

• Attention to detail and organizational skills
• Good interpersonal and communication skills
• Ability to work as a part of a team and promote a team environment