Quality Auditor

Shift Pattern

4 x 12-hour extended day shifts followed by 4 days off

Role Overview

The Quality Specialist provides direct quality support to a designated production area as part of an Integrated Product Team (IPT). Reporting to the Associate Director of Quality Operations, the role is responsible for ensuring product quality and compliance with Good Manufacturing Practices (cGMP) and Good Documentation Practices.

This position has a strong shop floor presence, offering real-time quality guidance and coaching to support right-first-time documentation and manufacturing execution. The role also involves reviewing process documentation for accuracy, completeness, and data integrity, supporting batch disposition activities, and contributing to deviation investigations.

Key Responsibilities

• Review and approve Master Batch Records (MBRs) and Electronic Batch Records (EBRs)
• Review executed batch records, logbooks, and production documentation for compliance with cGMP and internal procedures
• Maintain active shop floor presence to support compliance, data integrity, and quality culture
• Review and approve SOPs, Work Instructions, and controlled job aids
• Participate in Tier meetings to escalate issues and support timely resolution with cross-functional teams
• Provide QA support for commissioning and qualification lifecycle activities related to capital projects and new equipment
• Act as Quality SME for Performance Qualification (PQ) activities including equipment, facilities, utilities, cleaning validation, SIP, and process validation
• Contribute as the quality representative on cross-functional projects
• Support quality systems including Change Control, Deviations, CAPAs, equipment requalification, and periodic reviews
• Assist with internal audits and regulatory inspections
• Collaborate with cross-functional teams to drive continuous improvement initiatives
• Apply problem-solving tools and support operational excellence initiatives (e.g. MPS)

Experience, Knowledge & Skills

Required:

• Minimum 5 years' experience in GMP manufacturing, Quality Assurance, laboratory, or related pharmaceutical/biotech environment
• Strong working knowledge of QA operations within the biotech or pharmaceutical industry
• Understanding of cGMP requirements and regulatory expectations
• Proven leadership capability with strong written and verbal communication skills
• Demonstrated ability to work collaboratively in a team-based environment

Preferred:

• Experience with quality systems and GMP documentation authoring/review/approval
• Strong analytical, critical thinking, and problem-solving skills
• Experience coaching or mentoring team members
• Hands-on experience working on a manufacturing shop floor
• Familiarity with GMP documentation review and shop floor auditing

Education & Qualifications

• Bachelor's degree in a scientific or engineering discipline preferred
• Candidates with relevant experience in lieu of a scientific degree will also be considered