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Lead Microbiologist, QC Lab

Baxter International Inc
Mount Eden, California, US
Closing date
Jun 20, 2024

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Consultancy/Private Sector
Conservation science
Project Management
Salary Type
Employment Type
Full time
This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Your Role at Baxter

This position is responsible for implementing and executing microbiology related projects that are in support of improving lab and manufacturing processes and/or maintaining regulatory compliancy. Secondary functions include completing product release paperwork, performing trending, and purchasing supplies. Tertiary functions include conducting microbiological testing in support of manufacturing, raw materials, environmental systems, validations, projects, and shelf-life studies.

What youll be doing

• Responsible for the supervision of the Microbiology Department and a team of microbiologists. Coordinate daily operations for a team of microbiologists and laboratory assistants; ensure that objectives are set, monitored, and completed with proper priority.

• Responsibility for the routine microbiological monitoring of starting materials, finished products and environmental control systems and routine testing where required. Responsible for the generation of documented procedures for Microbiological monitoring and responsible for compliance with documented procedures.

• Responsible for the identification and communication of adverse trends in routine microbiological monitoring

• Oversee sterilization testing and testing to support manufacturing and new product development.

• Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.

• Your role will be to maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.

• Review and approve laboratory testing documentation.

• Facilitate, perform, and review laboratory investigations.

• Assist in the creation and maintenance of laboratory SOPs and validation documents for GMP lab test procedures and systems.

• Assist in the writing of functional area status reports, regulatory documents, and process descriptions.

• Maintain environmental monitoring program.

• Maintain risk assessments required for parametric release.

• Management of lab equipment including, Qualifications, e.g. IQ/OQ, calibration and maintenance

• Participate in all GMP and operational training programs & complete associated Training Records

• Participate in internal and external audits (including regulatory)

• Weekend work may be required as needed to meet production timeline schedules.

What youll bring

• B.S. degree in Microbiology, Biology, or related science

• Minimum of 5 years of experience or master's degree in biological science with 1-4 years experience, preferably in the pharmaceutical or medical device industry.

• Experience of Bioburden and Bacterial Endotoxin testing

• Familiarity and understanding of FDA and EU pharmacopoeial requirements.

• Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects

• Experience in supervising and motivating a team, project management experience and meeting deadlines.

• Excellent communication and interpersonal skills essential, proactive approach to work essential

• An ability to work independently as well as a member of a team in a dynamic, fast-paced environment essential.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law

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