Apply on Employer Site

Jubilant Pharma Limited · 1 day ago

Auditor II/III, Compliance

Spokane, WA

Full-time

Onsite

Mid, Senior Level

$78K/yr - $114K/yr

5+ years exp

Jubilant HollisterStier LLC is Spokane’s Largest Manufacturing Company, providing a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Compliance Auditor II/III role involves ensuring adherence to cGMPs and managing internal and supplier audit programs to maintain compliance with regulatory standards.

Health CareManufacturingPharmaceutical

Responsibilities

Ensure that JHS meets regulatory agencies expectations and customers' needs by auditing / monitoring key suppliers that provide material or services utilized for executing GMP activities

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 (TrackWise 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

Qualification

Quality systems knowledgeGMP complianceInternal auditsSupplier auditsRegulatory inspectionsCQA certificationSAP proficiencyTrackWise experienceMicrosoft OfficeCross-functional collaboration

Required

Bachelor's degree in related professional technical or life sciences degree/field or equivalent combined education and experience required

Minimum five (5) years of related experience required, must include Quality Unit experience

Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits required

This position requires knowledge of the Code of Federal Regulations, EU guidance, ISO and other industry regulations

Knowledge and interpretation of GMPs and quality systems required

Ability to inspect and identify deficiencies in documents, products and processes required

Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and TrackWise required

Potential travel 10% - 40% required

Requires use of personal protective equipment in designated areas required

Minimum ten (10) years of related experience, must include Quality Unit experience for Auditor III

Minimum of five (5) years of experience within a Pharmaceutical or FDA-regulated environment required for Auditor III

Preferred

CQA or equivalent desired, but not required

Experience with regulatory authorities and/or regulatory inspections desired

Benefits

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

Company

Jubilant Pharma Limited

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.

Founded in 2014

Singapore, Central Region, SGP

1001-5000 employees