Auditor II​/III, Compliance

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.

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.

• Ensures that JHS meets regulatory agencies expectations and customers' needs by auditing/monitoring key suppliers that provide material or services utilized for executing GMP activities. The Compliance Auditor accomplishes this by performing audits/monitoring in order to assess compliance to current GMP regulations, Jubilant policies, directives and procedures.
• Responsible for the development, maintenance and execution of the Internal and Supplier audit program and conducting GXP audits in accordance with the audit schedule including but not limited to:
• 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.
• Supports readiness of the facility for Regulatory Inspection. Assists site operations during regulatory and third party inspections, and serves as co-host when required as well as participating in associated tasks.
• Completes department related Change Controls, CAPAs and Deviations as required.
• Works cross functionally on improvement projects related to audit compliance, supplier qualification and other quality-related subjects within the organization.
• Review and approve component specifications and SAP source lists.
• Support compliance efforts and represents QA on projects related to new suppliers or materials.

• Bachelor’s degree in related professional technical or life sciences degree/field or equivalent combined education and experience required.
• CQA or equivalent desired, but not required.
• Minimum five (5) years of related experience required, must include Quality Unit experience required.
• Minimum Two (2) years of experience within a pharmaceutical/medical device or FDA regulated environment required.
• Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits preferred.
• Experience with regulatory authorities and/or regulatory inspections desired.
• This position requires knowledge of the Code of Federal Regulations, EU guidance, ISO and other industry regulations. It also requires knowledge and interpretation of GMPs and quality systems. The applicant should be able to inspect and identify deficiencies in…