QA Specialist II

Job Description

Title:

QA Specialist II

Duration: 12 months

Shift: Monday – Friday

Position Summary:

QA Specialist II is responsible for ensuring the quality of manufactured products and processes in accordance with standard operating procedures and Good Manufacturing Practices. The role involves CAPA investigations, process improvement, documentation, training, and regulatory compliance support.

• Assure quality of manufactured products and processes per SOP and GMP.
• Provide technical input to facilitate CAPA investigations and maintain the CAPA system.
• Communicate and collaborate effectively with team members and internal stakeholders; participate in cross‑functional teams.
• Maintain, review, and update relevant documents and records.
• Provide input into the annual departmental budget.
• Manage product and process improvements, monitor manufacturing performance, and implement approved improvement activities.
• Maintain and update computer applications related to the quality system.
• Support manufacturing and testing operations, adhere to GMP and GLP, stay current with industry standards, and complete required training via the Electronic Training Management System (ETMS).
• Share quality knowledge with colleagues and train others within key processes.
• Perform quality testing as appropriate for products, review data for conformance with specifications, and support plant environmental monitoring programs.
• Conduct incoming inspections, manage sample and file storage, and apply change‑control processes.
• Lead or assist in troubleshooting issues and applying problem‑solving skills to resolve them.
• Execute tasks assigned by Team Leader/Manager and support related activities.

• Bachelor’s degree in a science or closely related discipline, or equivalent relevant experience.
• 3–7 years of equivalent experience.

Work authorization in the U.S. is required; no sponsorship provided.

All information will be kept confidential according to EEO guidelines.