Tech II, QA Rec Retention

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 34,605 - 46,797; Full time

Benefits offered by this job

Flexible Spending Accounts (FSA)

Health Savings Accounts (HSA)

Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

Employee Assistance Program

Job summary

Jubilant Pharma, LLC in Spokane is hiring a QA Records Retention Technician to oversee site-wide documentation management and support client and regulatory audits. This position requires 2–3 years of relevant experience and offers a salary range of $25.12–$33.97 per hour.

The ideal candidate will have strong skills in MS Word, Excel, and Adobe Acrobat, along with the ability to prioritize tasks effectively. Comprehensive benefits start on day one, including flexible spending accounts and disability insurance.

Qualifications

• 2–3 years of related experience required.
• FDA regulated industry experience preferred.
• Ability to resolve minor discrepancies in SOP documentation.

Responsibilities

• Maintain and manage site-wide documentation.
• Coordinate transport of records between the facility and off-site storage.
• Support Manufacturing with document requests for timely closure of investigations.

Skills

Excellent computer skills

MS Word proficiency

Excel proficiency

Adobe Acrobat proficiency

Strong spelling, punctuation, and grammar skills

Conflict management skills

Ability to prioritize tasks

Education

High School Diploma or Equivalent

Associate's degree in Arts or Science

Job description

Jubilant HollisterStier Spokane 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.

1. Work independently, maintaining intermediate competence in all job functions with minimal guidance.
2. Maintain and perform administrative functions in various Records databases such as LUMAC, Access, and Librarika.
3. Receive, account for, locate, and house Manufacturing and Quality documents in a controlled access area daily according to the established format.
4. 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.
5. Account for and manage voided controlled paperwork such as machinabilities, demos, media fills, production records, HEPA, maintenance, and EM compliance logs.
6. Issue and retain facility LUMACS at high volume, logging appropriately to maintain traceability and prevent duplicate issuance, and conduct yearly LUMAC reviews.
7. 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.
8. Follow department procedures for the destruction of records and retention samples, both on and off site, coordinating approvals with Project Management.
9. Maintain retention sample areas under proper storage conditions, processing daily, monthly, and annual review requests, and record warehouse movements in the SAP database.
10. Communicate with QA Compliance to review and process client complaints, pulling appropriate APRs for Annual Product Review.
11. Support Manufacturing with document requests to drive timely closure of Investigations, PRs, CAPAs, and Change Controls.
12. Coordinate with the QA Document Systems Manager to provide client and regulatory audits with requested documents quickly.
13. Manage Quality shred bins for the weekly destruction of discarded documents through a contracted third party.
14. Initiate, revise, and collaborate on department SOPs as needed.
15. Provide input for investigations and Root Cause Analysis (RCA) on deviations and CAPA events.
16. 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 [e-mail].

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.