Tech II, QA Rec RetentionJubilant HollisterStier LLC • Spokane, Washington, United States
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Tech II, QA Rec Retention
Jubilant HollisterStier LLC
- Spokane, Washington, United States
- Spokane, Washington, United States
About
Work independently with minimal guidance as an intermediate experienced employee.
Maintain administrative functions in various records database types (e.g., LUMAC, Access, Librarika), ensuring accurate and consistent maintenance.
Digitally and physically locate and systematically house manufacturing and quality documents in a controlled access area according to record type.
Coordinate transport of records between the main facility and third‑party off‑site storage partner per SOPs.
Account for and manage voided controlled paperwork such as machinabilities, demos, media fills, production records, HEPA, maintenance, and EM compliance logs.
Process high‑volume issuance and retention of facility LUMACS, logging to maintain traceability and prevent duplicate issuance; conduct yearly LUMAC review.
Scan all CMO batch records for QA Release with an organized approach, ensuring standards for release/Client review and prioritizing critical batches.
Follow procedures for destruction of records and retention samples both on and off site, coordinating approvals with Project Management.
Maintain retention sample areas with proper storage conditions; process daily, monthly, and annual sample review requests and track warehouse movements in SAP.
Communicate with QA Compliance to review client complaints and pull APRs for annual product reviews.
Support manufacturing with document requests to facilitate timely closure of investigations, PRs, CAPAs, and change controls.
Coordinate with the QA Document Systems Manager to provide documents for client and regulatory audits efficiently.
Manage quality shred bins for weekly destruction of discarded documents via third party.
Initiate, review, and collaborate on SOP updates as needed.
Provide investigation support and RCA input for deviations and CAPA events.
Occasional call‑in off‑shift to support client and regulatory audits.
Qualifications
High School Diploma or Equivalent required.
Associate’s of Arts or Science preferred.
2–3 years related experience required.
Excellent computer skills, including proficiency with MS Word, Excel, and Adobe Acrobat.
Experience in FDA‑regulated industry preferred.
Strong attention to detail with proficiency in spelling, punctuation, and grammar.
Strong communication skills and ability to influence outcomes.
Ability to establish priorities for multiple tasks and adapt to changing priorities on short notice.
Ability to resolve minor discrepancies in SOP documentation with the initiator or department supervisor.
Physical Requirements
Prolonged sitting (approx. 90% of time) at a computer.
Must be able to lift 60 lbs unassisted.
Location Spokane, WA – On Site, Full‑Time
Compensation & Benefits Hiring Wage: $25.12–$33.97 (shift differential included) with opportunities for growth, promotion, and annual raises.
Benefits start on day one. The following benefits are available:
Medical, Dental & Vision coverage
Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
Life & AD&D Insurance
Short‑Term & Long‑Term Disability Insurance
Employee Assistance Program
Equal Opportunity Employer Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Languages
- English
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