Sr. Associate I, Quality Control

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

• To investigate failure of finished product (FP) / In-process (IP) product in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions.
• To ensure that preparation of reagents and volumetric solution and standardization on time.
• To perform periodic observation of retained sample.
• To initiate Change control (CcM) Non conformation report (NCR) Out of Specification (OOS) Document change record (DCR) etc.. QMS related documents.
• To do the work allocation in shift and ensure it complete within timeline.
• To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines.
• To review results of the tests against the specification & standard test procedure performed by team members.
• To investigate out of specification (OOS) Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions.
• To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC.
• To ensure availability the working & impurities standards as per various pharmacopoeias.
• To support & guide team members in implementing change control Corrective and preventive actions (CAPA) and check effectiveness of CAPA give suggestions wherever necessary.
• To guide and support team members for performing all test for in-process product & finish product as per the specification and schedule.
• To train team members on current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) with support from Sub-Department Manager.
• To prepare SOP as and when required.
• To check verify and review the calibration of all the analysis instruments whether performed as per the schedule.
• To check completion of method transfer successfully in coordination with Analytical Development Lab (ADL) Department.

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.

Reasonable Accommodations

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