Quality Analyst I (3rd shift)

About the role

The Quality Analyst I Batch Release is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Release. He or she is responsible for performing final batch record review, reconciling discrepancies, compiling documentation packets, managing sign-out/sign-in processes, assisting with correction resolution, facilitating teamwork, and participating in continuous improvement projects.

Responsibilities

• Perform final batch record review
• Reconcile discrepancies with documentation and/or electronic systems as appropriate
• Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation
• Generate additional batch documents for batches in progress, such as supplemental batch record sections and controlled forms
• Manage the process of sign-out and sign-in of batch records
• Assist with correction resolution, providing controlled access to executed records requiring documentation corrections
• Facilitate an environment of teamwork and communication between Quality Assurance, Production, and other support functions to ensure on-time Quality review of batch records
• Participate in continuous improvement projects to enhance department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction

Qualifications

• Bachelor’s degree in a science discipline or bachelor’s degree in non-science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience
• Demonstrated understanding of quality assurance in an FDA-regulated environment and aseptic processing operations
• Effective organizational, technical, and problem-solving skills
• Computer proficiency in Microsoft Word, Excel, and Outlook, and ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements

• Must wear appropriate personal protective equipment as applicable
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time