Baxter Quality Analyst in Bloomington, Indiana
Quality Analyst I, Batch Review
Summary : The Quality Analyst I Batch Reviewer is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Review. He or she performs review of all quality documentation generated during filling operations. 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 Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
Performs Quality review in classified areas, r eports errors, deficiencies, discrepancies and observations to management. Expected to escalate when product safety is or may be compromised.
During in-process review, ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.
Initiates event investigation reports.
Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
Job Requirements (Education, Experience and 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.
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 PPE as required for various manufacturing areas
Must be able to gown qualify for Grade C/D areas.
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.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy
Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail toAmericas_TTA@baxter.comand let us know the nature of your request along with your contact information.
Organization: *Global Quality - US/Canada Operations
Title: Quality Analyst
Requisition ID: 180008EX