QC Document Controller

Argenta (New Zealand); Scotland; On-site; GBP 32,000 - 52,000; Full time

Job summary

Argenta is hiring a QC Document Controller to own and maintain the QC document control system, ensuring SOPs, methods, specifications and records meet GMP and Data Integrity requirements. You will support the QC lab to stay inspection-ready and serve as the go-to contact for document queries.

Ideal candidates will have GMP-regulated document control experience, strong attention to detail, and the ability to work across functions, ensuring timely reviews and accurate documentation in a fast-paced

Qualifications

• Experience of document control within a GMP-regulated environment.
• Strong knowledge of GMP, Good Documentation Practice and Data Integrity (ALCOA+) requirements.
• Experience using electronic document management and quality management systems.
• Understanding of change control, CAPA, deviation and training processes.

Responsibilities

• Follow Health and Safety practices and policies and promote safe working in the QC area.
• Ensure documentation meets GMP, GDP and Data Integrity requirements; escalate when quality is compromised.
• Manage lifecycle of QC SOPs and analytical methods, including formatting, routing, approval, issue, and reviews.
• Maintain controlled specifications, test methods, validation and stability protocols with version control and traceability.
• Issue, track and reconcile logbooks, worksheets and templates; ensure records are complete and filed.
• Archive, retain and retrieve QC records per retention requirements.
• Maintain training records and track document-related training upon issue or revision.
• Support change control, CAPA and deviation actions related to documentation; track closures.
• Provide document control reporting and support audits by retrieving records.
• Administer electronic document management and quality systems and assist users with issues.
• Act as contact for QC document queries and identify process improvements.

Skills

Attention to detail

Communication skills

Organisational skills

Teamwork

Independent work

Education

HNC or Degree in Chemistry/Pharmacy/Biology

Tools

Electronic document management systems

Quality management systems

Job description

At Argenta, we’re more than a company - we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.

Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions cover every stage of the process, from molecule to market.

We are in a unique position: the world’s only combined contract research and contract development and manufacturing organisation (CRO/CDMO) dedicated solely to animal health.

We are ambitious, growing, and building aOne Teamculture, grounded in our values:

• We are team players.
• We are doers.
• We are customer-centric.
• We are innovators.

As a global company, we value diversity and the richness it brings - across locations, career stages, backgrounds, and experiences. When every person brings their best “paw” forward, we make animals' lives better.

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose:Healthy Animals. Let’s Make It Happen, Together.

Team players who want to do great work and find innovative ways to make animals’ lives better through our customer-centric efforts should apply.

About the Role

The QC Document Controller will be responsible to own and maintain the QC document control system, ensuring SOPs, analytical methods, specifications, protocols, controlled records and training records are accurate, current, traceable and compliant with GMP and Data Integrity requirements. The role enables the QC laboratory to work right first time and remain inspection-ready, provides a reliable point of contact for document queries and supports continuous improvement.

Experience

• Pharmaceutical, laboratory or related environment awareness

Key Responsibilities:

• Follow Health and Safety practices and policies by reporting incidents and hazards and promote safe working in the QC area.
• Ensure QC documentation meets GMP, Good Documentation Practice and Data Integrity requirements, and escalation situations where quality is compromised.
• Manage the lifecycle of QC SOPs and analytical methods, including formatting, review routing, approval, issue, periodic review and withdrawal.
• Maintain controlled specifications, test methods, and validation and stability protocols and reports, ensuring version control and traceability.
• Issue, track and reconcile controlled logbooks, worksheets and templates, and check that completed records are complete and filed.
• Manage the archiving, retention and retrieval of QC records in line with retention requirements.
• Maintain training records and assign document-related training when documents are issued or revised, tracking completion with managers and team leads.
• Support change control, CAPA and deviation actions relating to documentation, and track closure of document-related actions.
• Provide document control reporting (e.g. documents in workflow, overdue reviews) and support regulatory and client audits by retrieving and presenting records.
• Administer and use electronic document management and quality systems, support users and system issues.
• Act as the point of contact for QC document queries, coach colleagues on document control requirements, and identify improvements that make document processes simpler and more efficient.
  

Qualifications:

• HNC or Degree in relevant scientific Discipline (e.g. Chemistry/Pharmacy/Biology)
• Experience of document control within a GMP-regulated environment, ideally a pharmaceutical QC laboratory.
• Strong knowledge of GMP, Good Documentation Practice and Data Integrity (ALCOA+) requirements.
• Experience of using electronic document management and quality management systems.
• Understanding of change control, CAPA, deviation and training processes.
• Excellent attention to detail and accuracy.
• Strong organisational skills, with the ability to prioritise and meet deadlines in a changing environment.
• Good written and verbal communication skills, with the ability to work with colleagues at all levels.
• Ability to work independently, as well as part of a team across different functions, and to lead and guide team members.