Quality Assurance Associate

Quality Assurance Associate

Responsibilities

• Support QA Systems in conjunction with the Quality Assurance Manager.
• Provide direction on the execution of quality processes for ACT facility employees, providing guidance and expectations on how those systems are to be followed.
• Help manage the critical document control system.
• Ensure all facility documents are revised, made effective, and archived in a controlled manner according to appropriate governing policies.
• Track QA System progress either through internal auditing or the use of metrics.
• Help direct others who are executing validation work, review executed work, ensure work is completed against plan.
• Review executed batch records, identify corrections, and help resolve issues.
• Investigate occurrences and deviations and identify potential corrective and preventive actions to improve processes based upon QA system usage.
• Support the use of electronic quality management system.
• Assists in the process of creating batch records and forms needed to support the process.
• Completes initial review of batch records.
• Initiates and investigates deviations related to the manufacturing and release of products.
• Tracks and trends manufacturing errors and other metrics for KPIs.
• Supports material release, inspects incoming materials, and ensures they meet specifications for use within manufacturing.
• Technical Writer and resource for policies, Standard Operating Procedures, forms, worksheets, and job aids in support of quality and manufacturing operations.
• Aids and supports manufacturing in identifying needed policies, Standard Operating Procedures, and other required documents.
• Be a liaison for manufacturing to support projects.
• Maintain annual competencies in required quality functions and remain up to date in required EHS LMS modules.
• Aid in training other QA/QC members in ACT Quality Systems.
• Assist in the maintenance of quality electronic systems.
• Participate in 5 hours of continuing education annually in cellular therapy or quality topics.

Requirements

Experience with MasterControl is beneficial.

Qualifications

• Bachelor's degree in a relevant field (e.g., Quality Assurance, Engineering, Life Sciences).
• At least 2 years of experience in a similar role.
• Strong knowledge of quality assurance principles and practices.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

Benefits

Golden Technology offers a competitive benefits package including health insurance, retirement plans, and paid time off.

Pay

$XX per hour

Schedule

Full-time, 40 hours per week

About the Role

The Quality Assurance Associate at Golden Technology plays a crucial role in ensuring the quality and safety of products through the implementation and maintenance of quality systems. This position requires a strong commitment to quality and a willingness to learn and adapt to new technologies and processes.

Why Golden Technology?

Founded in 1997, Golden Technology has grown to become a trusted partner for Fortune 500 clients nationwide. Our company culture is centered around family, professional growth, and community impact through our Golden Community initiatives. We offer exciting opportunities with innovative companies, guidance from experienced recruiters, and a supportive professional environment built on trust and collaboration.