Quality Analyst I - Batch Review (weekend PM)

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 that is not part of the effective manufacturing batch record.
• As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types.
• Manage the process of sign-out and sign-in of batch records.
• Manage the process of correction resolution, assisting personnel with 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 in order to achieve internal targets and contractual commitments for batch release.
• Participate in continuous improvement projects to improve 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 the 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.