Auditor II/III, Compliance
Listed on 2025-12-02
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Quality Assurance - QA/QC
Data Analyst
Jubilant Hollister Stier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant Hollister Stier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma.
Jubilant Hollister Stier is a proud member of the Jubilant Pharma family.
Our Promise:
Caring, Sharing, Growing
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost effectiveness and wise investment of resources.
Job DescriptionThe Compliance Auditor II/III is a highly visible operational position of the Corporate Quality Compliance Team. The role of the Compliance Auditor is to ensure that the company is adhering to all cGMPs, including FDA and other applicable International Regulations, Guidance documents and Standards via performance of internal audits. The incumbent manages the Internal Audit and Supplier Audit Programs for GMP, GDP and GLP compliance, working closely with the operational functions to define and review processes, procedures, and systems to be audited annually.
The incumbent coordinates and develops with GXP operational groups and Quality Systems a holistic Quality auditing strategy.
- Creates and executes a systematic approach to conduct all audits presenting findings and recommended changes to procedures or practices that are not in compliance with stated regulations.
- Manages and maintains the Internal Audit and Supplier qualification programs, including associated Audit schedules, SOP's, Approved Supplier List (Track Wise PR records), and Supplier Quality Agreements, etc.
- Planning the scope and scheduling audit(s) with internal departments, and suppliers by creating an audit plan and identifying resources within Jubilant to assist with the audit, when applicable.
- Issue audit observations and reports as per the required deadlines requiring minimal edits from the approver.
- Reviews and evaluates Internal and Supplier audit responses to determine acceptability of the response and any applicable CAPA plans. Performs follow up activity to ensure effective CAPA implementation that resolves and documents issues pertaining to the internal and supplier audits in the approved audit tracking system.
- Leads for-cause audits as required to address suspected critical audit findings, fraud, or misconduct related to suppliers, or internal processes etc.
- Reporting metrics to Site, Department and Corporate Quality management.
- Bachelor's degree in related professional technical or life sciences degree/field or equivalent combined education and experience required.
- CQA or…
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