What are the responsibilities and job description for the Quality Specialist, SME position at Tjoapack?
Quality Specialist – Self Inspections (SME 3)
📍 Clinton, TN | Full-time
💼 Vacancies: 1
About Tjoapack
Tjoapack is a global contract packaging organization (CPO) specializing in primary and secondary pharmaceutical packaging and supply chain management services. With more than 30 years of experience, we use our expertise and the latest technologies to deliver flexible, compliant packaging solutions to customers across more than 45 countries worldwide.
Headquartered in Etten-Leur, the Netherlands, and operating in Clinton, TN since 2021, Tjoapack processes millions of medicine packages each year. Our mission is to shape the future of the pharmaceutical supply chain—making it safer, more reliable, and more patient-centric. Every decision we make is guided by one principle: patient safety comes first.
The Role
As a Quality Specialist – Self Inspections (SME 3), you are a key contributor to the Quality Assurance (QA) team and the integrity of Tjoapack’s Quality Management System (QMS). You support GMP compliance across operations while serving as the Subject Matter Expert (SME) for self-inspection activities.
In this role, you own the self-inspection program end-to-end—planning, executing, documenting, and continuously improving internal inspections. You also support broader QA responsibilities including document management, deviations, complaints, CAPA, and change control. This position is ideal for a quality professional who is detail-driven, independent, and passionate about continuous improvement in a regulated environment.
A Day in the Life 🔍
Your day may begin by reviewing inspection schedules and preparing documentation for an upcoming self-inspection. You conduct inspections on the floor or within support functions, identifying compliance gaps and opportunities for improvement. Throughout the day, you collaborate with Operations, QA colleagues, and leadership to discuss findings, agree on corrective actions, and track follow-ups.
You may facilitate Quality Management Review (QMR) meetings, support deviation investigations, or coach teams on GMP expectations. As the Self-Inspection SME, you regularly evaluate inspection effectiveness, incorporate industry best practices, and strengthen the inspection process to ensure ongoing inspection readiness and regulatory compliance.
What You’ll Do
🧾 Self-Inspection Program (SME Ownership)
Own and manage the self-inspection program as Subject Matter Expert.
Plan, schedule, conduct, and document self-inspections across departments.
Identify gaps, risks, and improvement opportunities related to GMP and internal standards.
Continuously improve the self-inspection process using feedback, metrics, and industry best practices.
🛡️ Quality Management System (QMS) Support
Execute QA tasks to maintain and improve the QMS, including document control, system monitoring, and user support.
Support audit and inspection readiness through robust internal controls and documentation.
Provide training and assistance to users of the QMS and Document Management System (Manual Master).
📊 Quality Management Review (QMR)
Support and facilitate the Quality Management Review process.
Prepare agendas, collect data, lead discussions, and ensure action items are documented and completed.
Continuously evaluate and improve QMR effectiveness and efficiency.
⚠️ Deviation & Complaint Management
Act as first point of contact for deviation and complaint-related questions.
Guide departments on compliance with deviation and complaint procedures.
Own customer quality communication related to deviations, complaints, and projects—from intake through resolution.
📝 Documentation, CAPA & Change Control
Develop, review, and approve SOPs, Work Instructions, Forms, and Training materials.
Review and execute CAPAs, Risk Assessments (RA), Change Controls (CC), and Validation activities.
Support root cause analysis and ensure sustainable corrective and preventive actions.
🎓 GMP Training & Operational Quality
Develop and organize Production QA and annual GMP training programs for office staff.
Ensure training materials remain current, relevant, and aligned with regulatory expectations.
What We’re Looking For
Required
Bachelor’s degree in a pharmaceutical, scientific, technical, or related discipline.
Experience working in a fast-paced, regulated environment.
Demonstrated experience investigating and resolving complex quality issues (e.g., RCA).
Experience planning, scheduling, and monitoring work to meet quality and time targets.
Broad knowledge of own specialty area with growing cross-functional understanding.
Familiarity with cGMP and/or cGDP requirements.
Strong analytical skills and high attention to detail.
Ability to identify and implement process improvements.
Full professional proficiency in English.
Why Join Us?
At Tjoapack, Quality is not a support function—it’s a core value. As a Quality Specialist SME, you will directly influence inspection readiness, regulatory compliance, and patient safety. You’ll work in a collaborative, improvement-focused environment with the opportunity to shape systems, processes, and behaviors that matter.
Health & Safety 🦺
Computer-based work is alternated with other tasks to promote movement and ergonomic balance.
Pre-Employment Requirements ⚕️
Employment at Tjoapack requires successful completion of:
Background check
Drug screening
Physical examination
These steps help us maintain a safe, compliant pharmaceutical environment.
Apply Now
If you’re a quality professional who thrives on ownership, continuous improvement, and inspection excellence, we’d love to meet you.
👉 Apply today to join Tjoapack as a Quality Specialist – Self Inspections (SME 3) and help protect patient safety through quality leadership.