Associate, QA ComplianceJubilant Pharma Limited • Spokane, Washington, United States
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Associate, QA Compliance
Jubilant Pharma Limited
- Spokane, Washington, United States
- Spokane, Washington, United States
About
provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of root cause analysis (RCA) of deviations and vendor complaints/issues. The role assures product compliance and product safety, ensures accurate and timely data entry, and oversees the company Quality Systems related to Deviation, CAPA and vendor complaint activities.
Responsibilities
Review deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs, policies, specifications and regulatory guidelines.
Facilitate deviation investigation/resolution, assess product impact and complete/writing final assessment/lot disposition for QA management and client review and approval.
Enter data into the database in support of corporate RCA and CAPA activities.
Provide oversight of investigational RCA group activities including preparation of meeting agenda, publishing of meeting minutes and follow‑up on agreed activities.
Interface with management and responsible individuals to ensure task completion on or before established due dates.
Support quality systems, processes and procedures (e.g., deviations, CAPA, vendor complaint) to assure compliance and product quality and safety.
Assist QA and applicable department management to ensure follow‑up and implementation of corrective actions resulting from deviations, audits or regulatory inspections.
Provide deviation and CAPA metrics as needed to support management review of system data.
Work extensively with appropriate departments to gain an understanding of the production/analytical testing process and other applicable processes to ensure capture of appropriate details and conclusions in investigation or corrective action documents.
Qualifications
Associate’s degree in biology, chemistry or related field required.
Bachelor’s degree in a science field desired; can substitute for experience.
Minimum two years of experience required; bachelor’s degree may substitute for experience, and five years of experience may substitute for an associate’s degree.
Sologic Certificate desired.
Experience in pharmaceutical and FDA‑regulated industry desired.
Experience with technical writing, investigations, CAPA systems, manufacturing processes/systems and QC analysis is highly desired.
Direct or supporting aseptic manufacturing experience in the bio/pharma industry desired.
Proficiency with Microsoft Word and Excel required.
Knowledge of cGMPs desired.
Basic communication skills required.
Ability to manage conflict and influence outcomes desired.
Location and Shift Spokane, WA – On Site, Full‑Time. Monday‑Friday, 8:00 AM – 5:00 PM.
Compensation Annual salary range: $58,047.50 – $78,494.46, with opportunities for growth, promotion, and annual raises.
Benefits (Start Day One)
Medical, dental and vision coverage
Flexible Spending Account (FSA) and Health Savings Account (HSA)
Life and AD&D insurance
Short‑term and long‑term disability insurance
Employee Assistance Program
EEO Statement 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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