Job opening
Quality Coordinator – Pharmaceutical Logistics
Filed under Biotechnology Research
Full job description
Quality Coordinator – Pharmaceutical Logistics
We are seeking a Quality Coordinator to support quality and compliance activities within a regulated pharmaceutical logistics and transportation environment. This is an excellent opportunity for an early-career Quality professional with 0–2 years of experience who is looking to build hands-on experience with Quality Management Systems (QMS), GDP/GxP compliance, audits, CAPA, deviations, supplier quality, documentation, and continuous improvement.
Working closely with the Regional Quality Manager and local operations teams, the Quality Coordinator will help ensure that operations comply with internal quality standards, customer requirements, and applicable regulatory requirements.
Key Responsibilities
- Support the local Quality Management System (QMS) and ensure quality procedures and documentation remain current and compliant.
- Serve as a local point of contact for routine quality and compliance questions, escalating more complex matters to Quality leadership as needed.
- Support internal, external, regulatory, and certification audits, including audit preparation, documentation/evidence collection, responses, and corrective-action follow-up.
- Assist with the investigation and documentation of deviations, non-conformances, incidents, and customer complaints.
- Support root cause analysis and Corrective and Preventive Actions (CAPA) and track actions through completion.
- Participate in risk assessments and change-control activities, ensuring changes are properly evaluated, documented, and communicated.
- Support the supplier qualification and monitoring program, including supplier documentation, evaluations, performance monitoring, and audit activities.
- Assist with the review and maintenance of SOPs, Work Instructions, quality records, audit reports, and other controlled documentation.
- Maintain quality information and documentation within systems such as MasterControl and SharePoint.
- Support training compliance, including maintenance of training matrices, assignment of required training, and follow-up on outstanding requirements.
- Assist with facility quality activities including calibration, maintenance, qualification/validation, temperature monitoring, pest control, and cleaning documentation.
- Conduct routine quality checks and self-inspections to identify potential compliance gaps and improvement opportunities.
- Support compliance with applicable Good Distribution Practices (GDP), GxP requirements, ISO standards, local regulations, customer requirements, and internal policies and procedures.
- Partner with Operations and Quality teams to identify and implement continuous process improvements.
- Participate in customer and supplier quality discussions as needed.
Qualifications
- Diploma or Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences, Quality Management, Engineering, Logistics, Life Sciences, or a related field.
- 0–2 years of Quality, Compliance, QA, pharmaceutical, healthcare, life sciences, logistics, or other regulated-industry experience.
- Basic understanding of Quality Management Systems and regulated quality processes.
- Exposure to GDP, GMP, GxP, ISO, CAPA, deviations, change control, audits, or controlled documentation is highly desirable.
- Strong written and verbal communication skills.
- Excellent attention to detail, organization, and documentation skills.
- Ability to manage multiple priorities and meet established deadlines.
- Strong interpersonal skills with the ability to work effectively with Operations, Quality, vendors, customers, and other cross-functional stakeholders.
- High level of integrity, accountability, and professionalism.
- Ability to work both independently and collaboratively within a team environment.
- Advanced proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
- Experience with MasterControl, SharePoint, or another electronic Quality Management System (eQMS) is a plus.
What We're Looking For
The ideal candidate is an early-career Quality professional who is detail-oriented, organized, and interested in developing broader experience within pharmaceutical and healthcare logistics. You do not need to be a senior Quality expert—we are looking for someone with a strong foundation who can learn quickly, follow established quality processes, identify potential compliance issues, and grow into greater responsibility with support from experienced Quality leadership.
Reports To: Regional Quality Manager, North America