Analyst 1, QualityReq # JR - 022344 Location Round Lake, Illinois, United States Job Category Quality Control Date posted 06/10/2020
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Responsible for generating Certificates of Conformance and Certificates of Analysis (CoC/CoA) for Finished Good products manufactured for Baxter by Contract Manufacturing Organizations. Responsible for coordinating Manufacturing Record Reviews (MRR) with Contract Manufacturing Organizations for product related complaints. Also responsible for ensuring manufacturing records associated with finished goods provided by Contract Manufacturing Organizations are complete and accurate for product release.
Essential Duties and Responsibilities
- Review and approve manufacturing records (batch and DHR records) for products manufactured by Contract Manufacturing Organizations to ensure accuracy and completeness. This may include a review of non-conformance reports related to the manufacturing of these products.
- Perform reviews of batch/DHR records and complaint history queries for complaint reports received for these products.
- Generate Certificates of Conformance and Certificates of Analysis (CoC/CoA) for these products.
- Utilize electronic systems for maintaining supplier quality records and uploading requirements.
- Assist with gathering data and creating reports for Annual Product Reviews for these products.
- Participate in continuous improvement activities and projects (i.e. CAPA, ECM Quality Improvement Teams). May lead projects as assigned by management.
- Interpret and execute policies and procedures that affect the organizational unit.
- Interact frequently with functional peer groups, area management, and Baxter’s suppliers.
- Manage workflow: identify and escalate issues as needed
- Other duties, tasks or projects as assigned/required
- Knowledge of FDA Quality System and Medical Device Reporting regulations (21 CFR 803/820 and 21 CFR 210/211).
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems for word processing and maintaining supplier quality records.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
Education and/or Experience
- Bachelor’s degree in science, engineering or another technical area.
- 1 – 3 years of experience working in the pharmaceutical, medical device, or Biotech industry preferred.
- Prior experience working with TrackWise preferred.
- Familiarity with FDA and ISO 13485 requirements preferred.
- Prior experience with TrackWise, JDE Warehouse Management system, reviewing manufacturing batch record / DHR documents and reviewing/approving non-conformance investigations related to finished goods preferred.
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.
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Pay Transparency Policy
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 to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.