Quality Assurance Associate

Job Description

Job Summary:

• The person in this position will be responsible for supporting QA Systems in conjunction with the Quality Assurance Manager.
• This person provides direction on the execution of quality processes for ACT facility employees, providing guidance and expectations on how those systems are to be followed.
• This person will help manage the critical document control system.
• Ensuring all facility documents are revised, made effective, and archived in a controlled manner according to appropriate governing policies.
• The person will also track QA System progress either through internal auditing or the use of metrics.
• Person will help direct others who are executing validation work, review executed work, ensure work is completed a Productst plan.
• Person will be responsible for the review of executed batch records, identify corrections, and help resolve issues.
• Based upon QA system usage the person will investigate occurrences and deviations and identify potential corrective and preventive actions to improve processes.
• This person will support the use of electronic quality management system.
• Batch Record Issuance: Assists in the process of creating batch records and forms needed to support the process.
• Batch Review: Completes initial review of batch records· Initiates and investigates deviations related to the manufacturing and release of products.

Duties and Responsibilities:

• Responsible for tracking and trending manufacturing errors and other metrics for KPIs.
• Support Material Release, inspecting incoming materials and ensuring 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.
• Assists 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.
• Assist 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.
• Responsibilities may be modified or added as needed and discussed with the QA Manager and/or Directors.

Education and Experience:

• Min. BS needed with 1+ years of relevant experience.
• Experience with Master Control is beneficial.