QA Records & Documentation Specialist (On-Site Spokane)

Jubilant HollisterStier LLC; Spokane (WA); Sur place; USD 33 000 - 47 000; Plein temps

Avantages offerts par ce poste

Medical, Dental & Vision coverage

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Résumé du poste

Jubilant HollisterStier LLC in Spokane, WA is seeking an experienced Records Administrator to maintain and manage manufacturing and quality documents in controlled databases. The role supports audits, regulatory compliance, and batch release processes while ensuring documentation integrity and fast retrieval.

You will work with LUMAC, Access, Librarika, and SAP systems, handle restricted access records, and coordinate with QA Compliance to drive timely investigations and CAPAs, with

Qualifications

• High School Diploma or Equivalent required.
• Associate degree preferred.
• 2-3 years related experience.
• Proficient with MS Word and Excel.
• Experience with FDA-regulated industry preferred.

Responsabilités

• Maintain and locate Manufacturing and Quality records daily.
• Manage document storage in controlled access areas.
• Coordinate transport of records to off-site storage per SOPs.
• Account for voided controlled paperwork and logs.
• Issue and log LUMAC records to ensure traceability.
• Scan CMO batch records for QA Release with priority.
• Follow destruction of records procedures and retention samples.
• Maintain retention sample areas and SAP movements.
• Communicate with QA Compliance for client complaints and APRs.
• Support investigations, PRs, CAPAs, and change controls.
• Collaborate with QA Document Systems Manager for audits.
• Manage record shred bins with third-party vendor.
• Contribute to SOP updates and revisions.
• Provide RCA input for deviations and CAPA events.
• Occasional off-shift support for audits.
• Ensure prioritization and resolution of document issues.

Connaissances

Attention to detail

Organizational skills

Communication skills

Prioritization

Documentation discipline

Formation

High School Diploma or Equivalent

AA/AS preferred

Outils

LUMAC Database

Access Database

Librarika Database

SAP

Description du poste

Jubilant HollisterStier LLC in Spokane, WA is seeking an experienced Records Administrator to maintain and manage manufacturing and quality documents in controlled databases. The role supports audits, regulatory compliance, and batch release processes while ensuring documentation integrity and fast retrieval.

You will work with LUMAC, Access, Librarika, and SAP systems, handle restricted access records, and coordinate with QA Compliance to drive timely investigations and CAPAs, with