Quality Assurance Specialist

Quality Assurance Specialist

Company: Datwyler

Location: Pennsauken, NJ, US, 8110

Date: May 28, 2026

This position handles the quality requirements and standards for manufacturing products in a GMP-regulated environment. Being a hands‑on person, the incumbent will support the site quality system and procedures in alignment with the global group quality policies and applicable industry standards. The responsibilities will be focused on the operations of a state‑of‑the‑art, clean, pharma packaging manufacturing environment.

• Support the site to guarantee continuity of Quality systems and activities according to global and local standards and at acceptable cost. Partner with operations to support site objectives and balance quality requirements, compliance and costs.
• Manage and maintain the Quality Management System: ensure the compliant status of the QMS with the requirements of ISO 9001, provide interdepartmental assistance to ensure that controlled documents reflect current practice and improve the flow of the documentation process.
• Support customer complaints, internal quality notifications, change control process, the CAPA process, and investigations related to complaints and nonconformances. Define and implement quality‑related projects to significantly improve quality and compliance levels.
• Support internal and external audit performance (customers, regulatory agencies, ISO and suppliers), follow up on audit outcomes, manage corrective actions and conduct training of internal auditors. Prepare for external audits and EHS certifications.

• Bachelor’s or Master’s Degree preferred.
• 3–5 years of relevant QA experience.
• Experience in classified areas preferred.

• Thorough knowledge of cGMP regulations and current industry practice.
• Knowledge of ISO 9001 and ISO 15378.
• Good knowledge of domain‑specific legislation, relevant standards and procedures.
• Fluent in English, both verbal and written.
• Experience in a customer‑facing role desirable.

The work of this position requires sitting in an office environment in front of a computer screen for approximately 80% of the workday. Occasionally lifting, pushing or pulling between 5 and 15 pounds and standing or walking in the facility. The employee must use computer equipment involving repetitive motion and may need personal protective equipment such as closed‑toe shoes, safety glasses, gloves or protection from high noise levels where required.

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