Quality Specialist

The Quality Specialist drives continuous improvement of the Quality Management System and ensures compliance with ISO 9001, GMP/GDP, FDA, and other applicable regulatory standards. This role plans, implements, and maintains quality assurance programs, supports production quality in a cleanroom assembly environment, and leads root cause investigations and corrective actions. The Quality Specialist collaborates closely with cross-functional teams to resolve quality issues, manage external customer complaints, and optimize processes through data-driven analysis and robust document control.

Responsibilities

• Continually improve, establish, coordinate, and monitor the Quality Management System to ensure effectiveness and compliance.
• Plan, develop, and implement quality assurance programs that support company objectives and regulatory requirements.
• Work closely with managers and supervisors to plan, schedule, and implement quality assurance activities across operations.
• Implement corrective actions in processes as required and verify their effectiveness.
• Review and approve analytical reports and Certificates of Analysis for compliance with specifications and quality standards.
• Create, develop, and/or approve standard operating procedures, work instructions, and related controlled documents.
• Serve as document owner responsible for document creation, maintenance, version control, and compliance for assigned processes.
• Prepare and maintain computer programs and tools for compiling and performing statistical analysis of quality assurance data.
• Develop and deliver training on quality-related processes, procedures, and standards to ensure consistent understanding and execution.
• Investigate quality events, discrepancies, noncompliance issues, corrective and preventive action (CAPA) reports, and complaints.
• Identify and define corrective and preventive actions in procedures and processes to address root causes and prevent recurrence.
• Manage and maintain quality system databases and prepare quality trending reports to support decision-making and continuous improvement.
• Participate in quality and planning meetings and contribute to Corrective Action Team activities.
• Perform standard quality assurance and quality control evaluation procedures, including statistical data analysis and interpretation.
• Make recommendations to management based on analysis results and support the development and presentation of training programs and documentation.
• Formulate and maintain process validation and quality control objectives aligned with company vision and goals.
• Interact professionally with associates, clients, and suppliers while fostering an atmosphere of cooperation, teamwork, and respect, even under pressure.
• Complete audit documentation and paperwork as defined and required by internal procedures and external regulations.
• Implement tactical and operational quality assurance goals focused on compliance with quality standards and continuous improvement.
• Contribute to the implementation of new testing protocols, inspection processes, regulatory compliance measures, and operational quality assurance plans.
• Manage quality assurance projects and processes, including supplier audits, process validation initiatives, and product quality enhancement efforts.
• Analyze complex quality issues that require evaluation of multiple factors, such as balancing production efficiency with defect reduction and resolving testing inconsistencies.
• Develop solutions based on limited information and precedents, including proactive defect prevention strategies and refined standard operating procedures.
• Apply root cause analysis methodologies to resolve complex manufacturing quality issues and strengthen process robustness.
• Communicate effectively with internal stakeholders, customers, vendors, and regulatory bodies to align on quality standards and address compliance concerns.
• Drive quality initiatives that support production quality in a manufacturing and cleanroom assembly environment.
• Support and manage external customer complaints, ensuring thorough investigation, documentation, and resolution, while focusing on manufacturing processes and troubleshooting.
• Support batch record review and quality control activities to ensure product quality and regulatory compliance.

• Minimum of 3 years of experience as a Quality Assurance professional.
• Bachelor's degree in a scientific discipline (e.g., Sciences).
• Demonstrated experience with CAPA and quality investigations.
• Experience with GMP or GDP environments and practices.
• Hands-on experience with batch record review and quality control activities.
• Working knowledge of Quality Management Systems and quality management principles.
• Practical experience with ISO 9001 and related regulatory requirements.
• Strong background in root cause analysis and investigation methodologies.
• Experience working in an assembly or cleanroom environment.
• Proficiency in quality assurance, compliance, and document control, including SOP management.
• Familiarity with FDA-related quality and compliance expectations in a pharmaceutical or similarly regulated environment.
• Clear and effective communication skills, both written and verbal.
• Strong time management skills with the ability to prioritize and meet deadlines.
• Proven ability to work effectively in a team-oriented environment with a collaborative mindset.

• Experience in pharmaceutical or highly regulated manufacturing settings.
• Experience with ERP systems, preferably Epicor and ETQ or similar platforms.
• Certification in Quality or Lean Six Sigma (preferred).
• Experience collaborating with cross-functional teams such as production, engineering, and supply chain.
• Experience managing and supporting external customer complaints while focusing on internal manufacturing and process troubleshooting.
• Ability to analyze quality data using statistical methods and translate findings into actionable improvements.
• Strong interpersonal skills with the ability to build cooperative relationships with associates, suppliers, and other stakeholders.
• Comfort working in a role that is primarily manufacturing process focused rather than client facing.

This position is based in a manufacturing laboratory environment with significant work performed in a cleanroom assembly setting. The role involves working on-site in Phillipsburg, New Jersey, within a production-focused facility that emphasizes adherence to strict quality, cleanliness, and regulatory standards. You will regularly interact with production, engineering, and quality teams, using ERP systems such as Epicor and ETQ, as well as computer-based tools for data collection and statistical analysis. The environment is collaborative and fast-paced, with a strong focus on teamwork, continuous improvement, and maintaining an atmosphere of respect and cooperation even during periods of high demand. Appropriate cleanroom and laboratory attire, including gowning and other protective equipment, is required in controlled areas to maintain product and process integrity.

Job Type & Location

This is a Contract position based out of Phillipsburg, NJ.

The pay range for this position is $33.00 - $43.00/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)

This is a fully onsite position in Phillipsburg,NJ.

This position is anticipated to close on May 1, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $33 - $43