Quality Associate - Data Entry

Job Description

Job Description

Job description

Immediate Opening! Quality Associate - Data Entry

We are seeking a highly detail-oriented Quality Associate - Data Entry.  In this role, you will be responsible for the management of GMP documentation for our area of operations and associated processes, including real-time design review, approval, and archiving. This position is ideal for a dedicated quality professional with a strong background in data entry, data validation, and good documentation practices within a regulated manufacturing environment.

Key Responsibilities

• Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements, focusing on raw material specification development and validation guides.
• Gather, rename, and upload supplier documentation (such as SDS, RIO, VAL, TSE, etc.) to Ithos for each material part number, using Syteline as a source. Create, edit, and maintain raw material entries and specification attributes across all sections in Ithos, ensuring accuracy and section-by-section review prior to saving.
• Build and maintain validation guides (Product Information Files/Formulas) in Ithos for final and in-process assemblies, including setting shelf life and storage conditions.
• Cross-reference assembly drawings and BOMs via Syteline to identify raw material components and resolve discrepancies using the Engineering Workbench.
• Maintain complete, current, and accurate raw material specification records in QT9 and Ithos, ensuring all document types are properly reviewed and archived. Collaborate with Engineering and Supply Chain teams to ensure drawings, BOMs, and raw material specifications are aligned and available.
• Verify part number descriptions and formats using Syteline reports to ensure complete consistency between Ithos entries and ERP system records.
• Ensure documents are properly entered into quality databases through scanning, indexing, filing, and archiving.

Qualifications

• Bachelor's degree in a technical or scientific field, or a High School Diploma with over 1 year of experience in Quality Assurance (2 to 4 years of work experience preferred).
• Proven experience in data entry, data validation, or quality assurance with a strong attention to detail and accuracy in data handling.
• Demonstrated ability to perform GMP operations following detailed SOPs while maintaining training and good documentation practices.
• Experience with technical documentation for quality activities, including quality inspections, corrective actions, and change control in a pharmaceutical or medical device environment.
• Understanding of global pharmaceutical product regulations with experience in ISO 9001 and/or 13485:2003 guidelines.
• Demonstrated ability to use computer databases for querying data, managing status, and inputting documentation, along with general Excel proficiency.
• Solid organizational, planning, and time management skills, with the ability to communicate effectively both verbally and in writing.
• Good general mathematical skills and the ability to work effectively and efficiently both independently and in a team environment

Discover a workplace that empowers you to thrive, innovate, and build the career you’ve been dreaming of.

Company Description

Discover a workplace that empowers you to thrive, innovate, and build the career you’ve been dreaming of.