Night Shift Quality Assurance Technician II

Actalent; Irvine (CA); Sur place; USD 36 000 - 39 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

HSA

Transportation benefits

Employee Assistance Program

Time Off/Leave

Résumé du poste

Actalent is seeking a Quality Assurance Technician II for a night-shift contract role in Irvine, CA. You will ensure sterile saline products meet quality standards, perform sampling, and maintain GDP-compliant records while inputting data in SAP.

The role emphasizes GMP/QA oversight, documentation accuracy, and problem solving in a fast-paced environment with regulatory compliance requirements.

Qualifications

• 2+ years of quality experience in the pharmaceutical or medical device industry.
• GMP experience in a regulated environment.
• Proficiency in FDA-regulated QA processes and quality control inspections.
• GDP documentation practices.
• Ability to input and manage data in SAP or similar enterprise software.
• Ability to follow SOPs and guidelines.
• Able to stand for long periods and lift 2035 lbs.

Responsabilités

• Monitor laboratory and manufacturing process verifications to ensure compliance with operating procedures, specifications, and established standards.
• Perform process monitoring activities, including receiving samples, controlling labels, overseeing the reinspection process, and conducting sampling for reserved samples.
• Provide quality oversight on processes to ensure compliance with internal procedures and regulatory requirements, with a strong focus on data integrity.
• Support quality investigations by gathering data, reviewing records, and assisting in the resolution of quality issues.
• Ensure complaint samples are archived as required and maintain accurate, organized records of all sample-related activities.
• Review documentation for accuracy and completeness while consistently practicing Good Documentation Practices (GDP).
• Input and manage sample information in SAP to ensure accurate tracking and traceability.
• Perform quality control inspections and physical testing of IV saline bags and related products according to established procedures and Good Manufacturing Practices (GMP).
• Follow all SOPs and guidelines, completing routine and repetitive assignments with a high degree of accuracy.

Connaissances

Quality Assurance

GMP

GDP

Data integrity

Documentation

Quality investigations

Lab testing

Formation

Bachelor's degree in science

Outils

SAP

ERP systems

Description du poste

Actalent is seeking a Quality Assurance Technician II for a night-shift contract role in Irvine, CA. You will ensure sterile saline products meet quality standards, perform sampling, and maintain GDP-compliant records while inputting data in SAP.

The role emphasizes GMP/QA oversight, documentation accuracy, and problem solving in a fast-paced environment with regulatory compliance requirements.