Lead Associate, QA Compliance

Jubilant HollisterStier LLC; Spokane (WA); On-site; USD 77,969 - 101,200; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Generous paid time off

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA, seeks a QA Compliance Lead Associate to support the Deviations, CAPA program, and vendor-related issues. You will review investigations, assess root causes, and ensure timely documentation and product compliance.

The role requires experience in pharma/fda-regulated environments, MS Word/Excel proficiency, and the ability to lift 30 pounds as needed. Shift is Weekday Nights 6pm–6am with competitive compensation and benefits.

Qualifications

• 5–10 years of related experience required with an Associate's Degree.

Responsibilities

• Review deviations, investigations and CAPAs for accuracy, consistency, and compliance.

Skills

Leadership experience

Regulatory compliance

Problem-solving

Cross-functional collaboration

Education

Associate degree in Biology, Chemistry or related field

Bachelor's degree in a science field (preferred)

Tools

Microsoft Word

Microsoft Excel

Job description

Overview

Jubilant HollisterStier LLC, Spokane's largest manufacturing company, is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in allergenic extracts. Jubilant HollisterStier is a member of the Jubilant Pharma family.

Job Description

QA Compliance Lead Associate provides support to the Deviations, Corrective and Preventive Action (CAPA) program through assessment of Root Cause Analysis (RCA) of deviations and vendor complaints/issues. Ensure product compliance and product safety. Ensure accurate and timely data entry and oversight of the Quality Systems related to Deviations, CAPA and vendor complaint activities.

1. Review deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
2. Facilitates deviations investigations/resolutions, assesses product impact, and completes/writes final assessment/lot disposition for QA Management and Client review and approval.
3. Enters data into databases in support of corporate RCA and CAPA activities.
4. Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing information to participants, publishing meeting minutes, and follow-up on actions.
5. Interface with management to assure task completion on or before established due dates.
6. Support quality systems, processes and procedures (e.g., Deviations, CAPA, Vendor complaint) to assure compliance and product quality and safety.
7. Assist QA and relevant Department Management to ensure follow-up on corrective actions from deviations, audits or regulatory inspections.
8. Provide deviations and CAPA metrics as needed in support of management review of system data.
9. Collaborate with appropriate departments to understand production/analytical testing processes and ensure capture of details and conclusions in investigation or corrective action documents.
10. Provide investigation training to Quality Unit and other departments to ensure consistent handling of investigations across the company.
11. Address deviations during regulatory and client audits.
12. Assist with reviews and approval of minor deviations in the QMS system.
13. Assist with extension requests approvals when permitted by procedure.
14. Assist with RCA chart review for QAC team members.
15. Act as QA SME on Change Control records within the QMS.
16. Provide leadership and guidance to QAC team members.
17. Report performance issues to QAC supervisor as they arise.
18. Act as the QA Compliance Supervisor when requested by the QA Manager (in the absence of the supervisor).

Qualifications

• Associates Degree in Biology, Chemistry or related field required.
• Bachelor's Degree in a science field desired.
• 5 to 10 years related experience required with an Associate's Degree.
• Minimum of 3 years related experience required with a Bachelor's Degree.
• Pharmaceutical and FDA Regulated experience required.
• Experience with technical writing, investigations, CAPA system, manufacturing processes/systems, QA operations systems, and QC analysis.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Lead and supervisory experience desired.
• Ability to lift 30 pounds unassisted.
• Microsoft Word & Excel experience required.
• Knowledge of cGMPs desired.
• Prolonged sitting required.

Shift

Weekday Nights, Monday-Wednesday or Thursday 6pm-6am

Compensation & Benefits

• Hiring wage: $77,969.00 - $101,200 annually depending on experience, with opportunity for growth, promotion and annual raises.
• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Jubilant HollisterStier is an EEO/AA Employer. All 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.

Note: This description reflects the general expectations for the role and is not a complete listing of duties. If you require assistance applying for a position, please contact our HR Department at [e-mail].