Work Location: Middlesex County, New Jersey

Summary:

The Quality Assurance Specialist plays a vital role in supporting the Quality Department to ensure compliance with regulatory, industry, and client requirements. This position is responsible for assisting in the maintenance and improvement of the Quality Management System (QMS), supporting validation activities, and collaborating with various departments to uphold service quality and continuous improvement.

Responsibilities:

• Assist in executing validation and qualification activities in line with industry standards and customer requirements.
• Maintain and review validation documentation, equipment logbooks, and records under supervision.
• Support quality review and verification of incoming and outgoing shipments and related paperwork.
• Participate in drafting and investigating Corrective and Preventive Actions (CAPAs) and respond to customer feedback and complaints.
• Review and update standard operating procedures and support change control processes.
• Assist during internal, supplier, and customer audits by gathering documentation and supporting audit-related tasks.
• Provide support to programs such as environmental monitoring, pest control, and equipment calibration/validation.
• Collaborate with cross-functional teams to ensure ongoing improvement of the Quality Management System and adherence to ISO standards.

Qualifications:

• 2–5 years of experience in a Quality-related role within a GxP facility.
• Basic knowledge and experience with compliance to ISO, GDP, GDocP, cGMP, and/or CBER/CDER-regulated Quality Management Systems.
• Experience assisting with validation activities and reviewing or interpreting validation data.
• Foundational understanding of basic statistical analysis methods.
• Proficiency in Microsoft Office programs (Word, Excel, Outlook, PowerPoint).
• Strong written and verbal communication skills.
• Ability to prioritize tasks and manage workload under supervision to meet deadlines.
• Demonstrated integrity, accountability, and sound judgment in daily work.
• Ability to communicate effectively with management and business leaders in a global operations setting.
• Understanding of USA/EU GDP process standards.
• University/college degree, BA/BS (life science preferred) or minimum 4 years equivalent experience preferred.

Published Category: Quality & Validation