Quality Associate/Data Entry

Crossroads Staffing

Camarillo (CA)

On-site

USD 40,000 - 60,000

Full time

11 days ago

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Job summary

Crossroads Staffing is seeking a Quality Associate for data entry in Camarillo. This role involves overseeing GMP documentation management, including design review, approval, and archiving of quality assurance records.

Candidates should have prior experience in data entry or quality assurance and be proficient in Excel. Familiarity with pharmaceutical regulations is a plus. This is a fulltime position requiring solid organizational skills.

Qualifications

  • Prior experience in data entry, data validation or quality assurance.
  • Experience with technical documentation.
  • Ability to follow detailed SOPs, training, and documentation practices.

Responsibilities

  • Oversee management of GMP documentation.
  • Collaborate with Engineering and Supply chain teams.
  • Verify part number descriptions and formats.

Skills

Data entry experience
Technical documentation experience
Ability to follow SOPs
Proficient in Excel
Organizational skills

Job description

Quality Associate Data Entry Needed in Camarillo
Job Description

Will oversee the management of GMP documentation for area of operations and associated processes, including real time design review, approval and archiving. Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements, with a focus on raw material specification development and validation guide. Gather, rename, and upload supplier documentation SDS, RIO, VAL, TSE, REA, ROH, SLS, ENL, SPC, etc. to Ithos for each material part number, following document naming conventions and sourcing from Syteline. Create and edit raw material entries in the Ithos system, accurately populating all required in accordance with company procedures. Enter and save all raw material 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 creating formula entries, updating composition from drawing and BOM, and setting shelf life and storage conditions. Cross-reference assembly drawings and BOMs via Syteline to identify all raw material components to be included in validation guides, resolving discrepancies using the Engineering Workbench. Maintain complete and accurate raw material specification records in QT9 and Ithos, ensuring documentation is current revised within five years and all required document types are uploaded, reviewed, and archived per company procedures. Collaborate with Engineering and Supply chain teams to ensure drawings, BOMs, and raw material specifications are available and aligned in Ithos prior to validation guide creation coordinate corrections or missing documentation as needed. Ensures documents are entered in the quality databases, scanning, indexing, filing and archiving. Verify part number descriptions and formats using Syteline Where Used Report and Item Form to ensure consistency between Ithos entries and ERP system recor

Skills Required
  • Prior exp in data entry, data validation or quality assurance.
  • Exp with technical documentation.
  • Ability to follow detailed SOPs, training and documentation practices.
  • Proficient in Excel.
  • Solid organizational and planning skills.
Skills Preferred
  • Understanding of global pharmaceutical product regulations.
  • Exp with ISO 9001 or 134852003.
  • Exp working in biopharma or life sciences a plus.
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