Our client, a leading pharmaceutical company, is hiring a Quality Assurance Specialist consultant on a contract basis.
Work Location
Devens, MA/Hybrid
Summary
• 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.
DUTIES AND RESPONSIBILITIES
• Prepares documentation and deliverables per Standard Operating Procedures required for drug product disposition.
• Works in electronic systems such 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.
EDUCATION AND EXPERIENCE
• Preferred 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.
Pay: 60