Quality - Quality Assurance Specialist

1. PURPOSE AND SCOPE OF POSITION:

The Quality Assurance Product Disposition Specialist is responsible for supporting quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with Client policies, standards, procedures and Global cGMP. The role will aid in the routine and timely release of drug product in the Cell Therapy Facility and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP). 2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
• Previous work/academic experience where attention to detail and personal accountability were critical to success.
• Strong communication skills and the ability to follow written and verbal instructions.
• Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
• Knowledge of electronic systems including any of the following preferred: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.

3. DUTIES AND RESPONSIBILITIES

• Prepares documentation and deliverables per Standard Operating Procedures required for drug product disposition.
• Works in electronic systemssuch as SAP, Learning Management, and Document Management systems.
• Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.
• Perform the review of batch genealogy for all raw materials and components used in each batch to ensure that they are approved and released.
• Works in electronic systems such as SAP, Learning Management, and Document Management systems.
• Works on assignments of simple to moderate complexity where some judgment is required in resolving problems and making routine recommendations.
• May contribute to drafting, reviewing, or approving procedural documents.
• Other duties as required.

4. EDUCATION AND EXPERIENCE

• B.S., in science, engineering, biochemistry, related discipline, or its equivalent
• 0-2 years of directly relevant experience in a regulated cGMP environment.
• Any combination of education, experience, and military service in line with recommendations above will be considered.

5. WORKINGCONDITIONS:

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. #J-18808-Ljbffr TechDigital Group