Quality Specialist

Quality Specialist

As a Quality Specialist, you will be responsible for the continual improvement and management of the Quality Management System. You will work closely with managers and supervisors to plan, schedule, and implement quality assurance activities, ensuring compliance with analytical results and standard operating procedures.

Responsibilities

• Responsible for the continual improvement of the Quality Management System.
• Establish, coordinate, and monitor the Quality Management System.
• Work closely with managers and supervisors to plan, schedule, and implement QA related activities.
• Plan, develop, and implement quality assurance programs.
• Implement corrective actions in processes as required.
• Review and approve reports of analytical results/Certificate of Analysis for compliance evaluation.
• Create and develop or approve standard operating procedures.
• Serve as document owner responsible for document creation, maintenance, and compliance for processes.
• Prepare and maintain computer programs for compiling and statistical analysis of quality assurance data.
• Develop and present training for processes and procedures.
• Investigate quality events, discrepancies, noncompliance issues, corrective and preventive actions reports, and complaints.
• Identify corrective actions in procedures and processes.
• Manage and maintain databases for the quality system and prepare quality trending reports.
• Participate in quality and planning meetings and applicable Corrective Action Team activities.
• Perform standard quality assurance/quality control evaluation procedures, evaluate data using statistical methods for analysis, interpret results of analysis, and make recommendations to management.
• Formulate and maintain Process Validation and QC objectives based on company vision and objectives.
• Interact with associates, clients, and suppliers, maintaining an atmosphere of cooperation, teamwork, and respect even under stress.
• Complete audit paperwork as defined.

Essential Skills

• Bachelor's Degree in Sciences
• Quality experience with CAPA and Investigations
• Experience with GMP or GDP

Additional Skills & Qualifications

• Biology knowledge
• Data entry skills
• Experience with reagents

Work Environment

This position is based in a Manufacturing Lab located in Phillipsburg, NJ, USA. The work environment fosters collaboration and teamwork, ensuring a cooperative atmosphere even in stressful situations.

Job Type & Location

This is a Contract to Hire position based out of Bridgewater, New Jersey.

Pay and Benefits

The pay range for this position is $35.00 - $43.27/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Bridgewater, NJ.

Application Deadline

This position is anticipated to close on Oct 3, 2025.