QC Compliance Specialist
Biopharmaceutical Manufacturing
Hybrid (Full-time) | No Travel Required
Role Summary:
A fast-paced and innovation-driven biopharmaceutical and medical device manufacturer is seeking a Quality Control Compliance Specialist to support the introduction and lifecycle management of analytical equipment in the QC laboratory.
This role presents a fantastic opportunity to work at the intersection of compliance, quality systems, and instrumentation. You’ll be instrumental in ensuring analytical platforms are introduced and maintained in full alignment with regulatory requirements and internal quality standards, while also supporting cross-functional initiatives and continuous improvement efforts.
This is a full-time, hybrid role offering exposure to a wide range of technologies, teams, and compliance-driven projects, without the need for regular travel.
Key Responsibilities:
Equipment Lifecycle & Compliance Oversight
Lead and coordinate the implementation, upgrade, and qualification of QC lab instrumentation
Prepare and maintain key documentation, including User Requirement Specifications (URS), GxP assessments, SOPs, and Work Instructions
Review and approve validation and qualification protocols (e.g., IOQ, PQ) for new and existing equipment
Project Collaboration & Stakeholder Engagement
Serve as the primary point of contact for new equipment onboarding in the QC environment
Collaborate with internal teams such as Validation, QA, IT, Metrology, Data Integrity, and QC Analysts to ensure smooth and compliant execution of projects
Work closely with Project Managers to meet key milestones and timelines
Technical Systems Supported Instruments may include:
UPLC/HPLC systems
Capillary Electrophoresis (CE), Biacore
TOC Analyzers, Karl Fischer titrators
Plate Readers, O₂ Headspace analyzers
Microscopes, Balances, and other essential QC laboratory tools
Continuous Improvement & Quality Assurance
Drive and support Change Control Requests related to laboratory instrumentation
Ensure all compliance documentation aligns with regulatory standards and internal procedures
Promote and uphold safe working practices, reporting issues as required
Support audit readiness by maintaining up-to-date and inspection-ready documentation
Qualifications & Experience:
Education & Background
Degree in a relevant scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or equivalent scientific experience
Industry Experience
1–2 years of experience in a Quality Control, Quality Assurance, or compliance role within the pharmaceutical or biopharmaceutical industry
Skills & Knowledge
Strong understanding of analytical instrumentation within a GxP-regulated environment
Familiarity with qualification documentation and change control processes
Effective cross-functional collaborator with an ability to manage multiple stakeholders
Soft Skills
Proactive, organised, and solution-focused
Self-starter with the ability to manage tasks independently and deliver against deadlines
Strong written and verbal communication skills
Team player who builds trust and credibility across departments
What’s in it for you?
A hands-on, impact-driven role within a global biopharma manufacturing environment
Opportunities for development in compliance, project coordination, and cross-functional collaboration
Hybrid working with no travel requirements
Exposure to a diverse portfolio of analytical technologies and quality systems
A collaborative, quality-focused team committed to continuous improvement
This is a great opportunity for an emerging quality professional ready to take the next step in a compliance-focused role with technical impact. If you're looking for a collaborative, forward-thinking environment—let's connect!