Tech II, QA Rec RetentionJubilant Pharma, LLC • Spokane, Washington, United States
Tech II, QA Rec Retention
Jubilant Pharma, LLC
- Spokane, Washington, United States
- Spokane, Washington, United States
À propos
is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Description QA Records Retention Technician
– The primary responsibilities include receiving, retaining, and securely housing site‑wide documentation; maintaining order and accountability for retention sample vials throughout the facility; communicating with all departments for records retrieval; tracking and managing all off‑site records; executing administrative functions across multiple digital databases; supporting regulatory and client audits; and maintaining a controlled‑access area for facility records.
Work independently, maintaining intermediate competence in all job functions with minimal guidance.
Maintain and perform administrative functions in various Records databases such as LUMAC, Access, and Librarika.
Receive, account for, locate, and house Manufacturing and Quality documents in a controlled access area daily according to the established format.
Coordinate the transport of records between the main facility and the third‑party off‑site storage partner, adhering to SOPs for checkout, reprocessing, and re‑filing of document types.
Account for and manage voided controlled paperwork such as machinabilities, demos, media fills, production records, HEPA, maintenance, and EM compliance logs.
Issue and retain facility LUMACS at high volume, logging appropriately to maintain traceability and prevent duplicate issuance, and conduct yearly LUMAC reviews.
Scan all CMO batch records for QA Release with an organized approach, ensuring they meet Release/Client Review standards and prioritizing batches flagged as critical.
Follow department procedures for the destruction of records and retention samples, both on and off site, coordinating approvals with Project Management.
Maintain retention sample areas under proper storage conditions, processing daily, monthly, and annual review requests, and record warehouse movements in the SAP database.
Communicate with QA Compliance to review and process client complaints, pulling appropriate APRs for Annual Product Review.
Support Manufacturing with document requests to drive timely closure of Investigations, PRs, CAPAs, and Change Controls.
Coordinate with the QA Document Systems Manager to provide client and regulatory audits with requested documents quickly.
Manage Quality shred bins for the weekly destruction of discarded documents through a contracted third party.
Initiate, revise, and collaborate on department SOPs as needed.
Provide input for investigations and Root Cause Analysis (RCA) on deviations and CAPA events.
Occasionally call in off‑shift to support client and regulatory audits.
Qualifications
High School Diploma or Equivalent required.
Associate’s degree in Arts or Science preferred.
2–3 years of related experience required.
Excellent computer skills; proficiency with MS Word, Excel, and Adobe Acrobat required.
FDA regulated industry experience preferred.
Strong spelling, punctuation, and grammar skills desired.
Basic exchange of information skills.
Conflict management and influencing skills desired.
Ability to establish priorities for multiple tasks and respond flexibly to changing priorities on short notice.
Ability to resolve minor discrepancies in SOP documentation directly with the initiator or department supervisor.
Physical requirements:
Prolonged sitting (≈90 % of time) at a computer.
Ability to lift 60 lbs unassisted.
Interaction with all departments for storage and retrieval of records.
Routine environment with simple rules and detailed instructions.
Repetitive/patterned situations that require learned solutions.
Diverse situations necessitating new solutions and applications.
Adherence to detailed instructions and established routines.
Tasks with measurable impact on workflow and end results.
Resolution of minor issues with the affected departments, with major issues escalated to the department supervisor.
Location Spokane, WA – On‑site, Full‑time
Compensation & Benefits Hiring Wage:
$25.12–$33.97 (including shift differential). Salary growth opportunities, promotions, and annual raises available.
Benefits begin on day one and include:
Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
Life & AD&D Insurance
Short‑Term & Long‑Term Disability Insurance
Employee Assistance Program
Application Assistance If you require assistance applying, contact
JHS-TalentAcquisition@jubl.com .
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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Compétences linguistiques
- English
Avis aux utilisateurs
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