Sr Quality Assurance Analyst (Blood products)

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride. 

Your role at Baxter:

You, as Sr Quality Assurance (Blood products), will provide support in the implementation and maintenance of Baxter Healthcare's Quality Management System, ensuring compliance with Mexican health regulations, the requirements of export countries, and the company's internal policies. Supervise the accurate functioning of the system in storage and distribution activities involving blood components and other product lines. Ensure processes are performed accurately using a risk management approach driven by regulatory compliance and customer happiness. You will carry out tasks related to sampling, inspection, and disposal of imported finished products. These tasks follow current sanitary regulations and are done under the Sanitary Manager or Assistant Sanitary Responsible's supervision.

What you will be doing:

• Foster a culture of compliance with ethical business standards and practices in the organization.
• Driving the implementation of the ethics and compliance program and preventing, detecting, and correcting violations of the law, Baxter's policies, and behavioral standards.
• Implement Baxter's standards of behavior, policies and procedures, including but not limited to the Global Interactions Policy and Third-Party Policy and support processes.
• Identify Baxter's compliance and legal risks.
• You will coordinate and be responsible for blood product analysis before COFEPRIS and authorized third party laboratories. The role involves follow-up, timely planning, and handling vital supplies and foreign goods d products.
• Lead activities related to compiling the dossier for the release of blood supplies and designated imported products in compliance with current regulations.
• Assignment of disposal involving blood materials and imported products according to the documentation generated.
• Taking and control of samples for third parties and retention of blood products and other imported products.
• Review and analyze the documentary evidence in the blood product file. Integrate it and decide on release or rejection following regulatory and quality requirements in the JD Edwards system.
• Review of analytical reports issued by the authorized third-party laboratory, lead what is appropriate in case of results out of specification or trend.
• Preparation of product certificates using the results of local analyses.
• Sampling and release of semi-finished imported product.
• Provide support for handling and implementing analytical methods for blood products as well as goods sourced internationally. Coordinate with the approved external laboratory and handle validation and transfer strategies.
• Assist in supervising and verifying the maintenance of validated analytical methods. These methods are used in routine release processes for blood derivatives and other similar products.
• Planning, compilation and analysis of information to handle the preparation of the "Annual Product Review" reports of medicines and medical devices.
• Planning and management of the stability system related to hematological items as well as other specified imported items.
• Active participation in the processes of launching new products.
• Follow-up of inventory depletion processes derived from changes in product conditions.
• Ensure compliance with the conditions of registration and current sanitary authorizations.
• Control, maintain and safeguard the information file that is generated for each batch of blood product and imported product assigned.
• Attend internal and external audits as requested, providing support to the Health Supervisor or Deputy Health Supervisor.

What will you bring?

• 3 to 5 years of experience in Quality Assurance and Systems, preferably in warehouses for the distribution of medicines (blood products) along with healthcare equipment.
• Between three and five years of background in Quality Control, transfer of analytical methods, validation in conjunction with third-party laboratories.
• Pharmaceutical Chemist Biologist (QFB), Industrial Pharmaceutical Chemist (QFI), Pharmaceutical Engineer (IF), Chemical Engineer and/or profession related to pharmaceutical areas.
• Knowledge of the Local Health Regulation (COFEPRIS), particularly what is applicable to transfusion materials and international standards ISO 9001 / ISO 13485.
• Trend analysis.
• Windows's package management (Word, Excel, Power Point).
• Management of JD Edwards or ERP.
• Intermediate English.

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
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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