Laboratory Quality Specialist

TekWissen • Waltham, MA

2d • Onsite

About The Position

The Laboratory Quality Specialist II supports the management, maintenance, and continuous improvement of laboratory Quality Management Systems (QMS). The role focuses on quality compliance, accurate documentation, audit readiness, and continuous improvement. The specialist collaborates with cross-functional teams and internal and external stakeholders to maintain quality standards and comply with applicable regulatory requirements. This is a temporary, onsite assignment in Waltham, Massachusetts, with a stated duration of three months and a Monday-to-Friday schedule from 9:00 AM to 5:00 PM.

Requirements

• Bachelor's degree in Life Sciences, Biology, Biotechnology, or a related scientific discipline.
• Minimum 1 year of experience in a quality assurance, contract laboratory, or quality control (QC) laboratory environment.
• Experience working with a Quality Management System aligned with GCP, ISO 17025, or equivalent quality standards.
• Knowledge of CAPA, change control, non-conformance management, and risk management.
• Experience with quality documentation, document control, and audit support.
• Experience with Laboratory Information Management Systems (LIMS) and document management systems.
• Proficiency in Microsoft Office applications.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Strong interpersonal and cross-functional collaboration skills.
• Excellent organizational skills and attention to detail.

Responsibilities

• Manage, organize, maintain, and control quality documentation within the Quality Management System (QMS).
• Support successful completion of internal and external audits, ensuring audit readiness and compliance.
• Collaborate with cross-functional teams to develop, review, update, and implement quality instructions, procedures, and guidelines.
• Support continuous improvement initiatives, including Corrective and Preventive Actions (CAPA), Change Control (CC), non-conformance management, and risk assessments.
• Review and approve customer projects to ensure quality requirements are met before delivery.
• Support qualification, maintenance, and control of laboratory instruments and equipment.
• Work with internal departments and external customers to address quality-related requirements.
• Identify opportunities for process improvements and contribute to maintaining an effective and compliant quality system.

What This Job Offers

• Career Level: Entry Level