Vacancy expired!
1st shift (6:30 am to 3 pm) Pay is up to $25/hr.
Summary:The GMP Batch Record Reviewer is a member of the Finishing Department reporting directly to the Packaging Supervisor, Production. He or she performs a review of all quality documentation generated during filling operations. He or she performs a review of all quality documentation generated during packaging operations. He or she must communicate effectively with customer support departments to coordinate the batch review and release activities to meet internal commitments and contractual commitments. He or she must communicate effectively with production and customer support departments to coordinate batch review activities to meet internal commitments. Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):- Perform batch record review for GMP batches produced at Baxter for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
- Reconcile discrepancies with documentation and/or electronic systems as appropriate.
- Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Production 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.
- Perform final batch record review, product release / disposition of GMP batches produced at Baxter
- 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.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position may require standing for long periods of time.
Vacancy expired!