Quality Analyst I
927 S Curry Pike Bloomington, IN 47402 Bloomington, IN 47402 US
Target Pay Rate: 55-63k **salary will be commensurate with experience
The Quality Analyst I is a member of the Quality Assurance Team (QA) reporting directly to the Quality Manager, Batch Review. They perform review of all quality documentation generated during filling and/or packaging operations. They must communicate effectively with customer support departments to coordinate batch review and release activities to meet internal commitments and contractual commitments.
What you'll do:
- 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 collaboration and communication between Quality Assurance, Production and other support functions to ensure timely Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
- Initiates nonconformance 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.
- Issuance and distribution tasks for batch records and logbooks
- Scanning of released batch record documentation
- Document retention tasks
What you'll bring:
- Bachelors degree (preferred and in a science field) or 6 years of experience in a regulated industry
- 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:
- 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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.