QC Inspector II

Work Location: Middlesex County, New Jersey

Summary:

The QC Inspector II plays a key role in ensuring the accuracy of incoming and outgoing shipments, maintaining compliance with Quality Management Systems, and supporting continuous improvement in quality processes. This position requires experience with ISO standards, cGMP, and quality documentation, as well as the ability to work collaboratively with quality and operations teams.

Responsibilities:

• Verify the accuracy of daily incoming and outgoing shipments, ensuring compliance with established standards and documentation requirements.
• Review and maintain internal documentation and logbooks, ensuring all records are accurate and up to date.
• Utilize monitoring software to generate data graphs and reports, and provide these to clients as needed.
• Conduct testing and validation of monitoring software to ensure proper functionality and data integrity.
• Follow Standard Operating Procedures, Safety Policies, and Good Manufacturing Practices to maintain compliance in all job functions.
• Provide effective training and hands-on guidance to team members on Quality Control Inspection documents and procedures.
• Support Quality Assurance activities during customer, internal, and regulatory audits, including equipment calibration and validation.
• Collaborate with operations and quality teams to drive continuous improvement initiatives and support change controls and equipment management changes.

Qualifications:

• High school diploma or equivalent required.
• 2 years of experience in a GMP manufacturing or Quality Control setting preferred.
• Experience in assembly/production line, lean/5S, materials management, or inspection is beneficial.
• Proficiency with Microsoft Office, Salesforce.com, and equipment-specific software.
• Excellent communication skills, including technical writing and spreadsheet management; able to communicate clearly in person and via email.
• Highly organized, detail-oriented, and able to meet performance expectations on schedule.
• Comfortable working in a fast-paced environment and able to adjust workload based on changing priorities.
• Ability to perform repetitive operations with high accuracy, conduct visual inspections, and lift up to 50 lbs; good visual acuity, color perception, and manual dexterity required.
• Must not have unusual sensitivity to typical laboratory chemicals (e.g., sanitization agents).
• Willingness to work overtime and weekends as needed.

Published Category: Quality & Validation