Analyst II QC Lab

RXinsider LTD.; Hayward (CA); On-site; USD 72,000 - 99,000; Full time

Benefits offered by this job

401(k) plan

Job summary

Baxter is seeking a QC Specialist to perform advanced microbiology testing and provide technical guidance to junior staff in a cGMP environment. You will support investigations, method validations, and equipment qualification activities while ensuring data integrity and regulatory compliance.

The role involves reviewing data, coordinating with external vendors, and supporting audits and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific field.
• 2-5 years of experience in a regulated laboratory environment.
• Working knowledge of cGMP, GLP, data integrity, and GDP.

Responsibilities

• Perform advanced microbiological testing using approved methods and procedures.
• Support environmental monitoring, bioburden, endotoxin, and other analyses.
• Mentor and train Analyst I personnel on procedures and data documentation.
• Review laboratory data and reports for accuracy and regulatory compliance.
• Coordinate with external vendors for calibration, troubleshooting, and testing services.

Skills

Analytical skills

Problem solving

Organizational skills

Communication skills

LIMS

Microsoft Office

Education

Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or related field

Tools

LIMS

Job description

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

Performs advanced quality control testing and laboratory support activities to ensure product quality and compliance with regulatory requirements. Executes complex microbiological or chemical; supports investigations, method qualifications and validations, equipment calibration activities, data review, and laboratory continuous improvement initiatives. Provides technical guidance to QC Analyst I personnel and helps maintain inspection readiness in accordance with cGMP, GLP, SOP, and data integrity requirements. Supports laboratory investigations, NCR/CAPA activities, sample shipments to third-party laboratories, and coordination with external service providers.

What You'll Be Doing

• Perform advanced microbiological testing using approved methods and procedures.
• Execute and review environmental monitoring, water testing, bioburden, endotoxin, and other microbiological analyses.
• Support environmental monitoring investigations and assessment of microbiological excursions.
• Trend microbiology data and identify adverse trends, recurring issues, and opportunities for improvement.
• Support microbiological method qualifications, verifications, validations, and transfers.
• Perform and support equipment calibration, maintenance, qualification, and troubleshooting activities.
• Review laboratory data, test records, and reports for accuracy, completeness, and compliance.
• Assist with laboratory investigations, deviations, NCRs, CAPAs, and change control activities.
• Support internal audits, customer audits, and regulatory inspections.
• Mentor and train Analyst I personnel on laboratory procedures, testing techniques, and documentation practices.
• Support procurement of laboratory supplies, media, reagents, and consumables required for testing activities.
• Coordinate with external vendors for equipment calibration, troubleshooting, maintenance, and contract testing services.
• Prepare, package, and ship samples to third-party laboratories while maintaining proper documentation and chain of custody.
• Ensure compliance with SOPs, cGMP, GLP, safety requirements, and data integrity principles.
• Perform advanced chemical and physical testing of raw materials, in-process samples, and finished products using established analytical methods.
• Complete complex analytical techniques and provide technical support for routine laboratory operations.
• Troubleshoot analytical methods, instrumentation, and laboratory processes to ensure reliable and accurate results.
• Support Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, nonconformance, and laboratory investigations.
• Assist with analytical method qualifications, validations, verifications, and transfers.
• Perform and support equipment calibration, maintenance, qualification, and troubleshooting activities.
• Review analytical data, calculations, chromatograms, and laboratory documentation for accuracy and compliance.
• Support laboratory projects, process improvements, and continuous improvement initiatives.
• Provide technical guidance and mentorship to Analyst I personnel.
• Support procurement of laboratory supplies, standards, reagents, and consumables required for testing activities.
• Coordinate with external vendors for equipment calibration, troubleshooting, maintenance, and contract testing services.
• Prepare, package, and ship samples to third-party laboratories while maintaining proper documentation and chain of custody.
• Support NCRs, CAPAs, and quality system activities related to laboratory operations.
• Ensure compliance with SOPs, cGMP, safety requirements, and data integrity principles.

What You'll Bring

• 2-5 years of experience in a regulated laboratory environment.
  Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific field.
• Working knowledge of cGMP, GLP, data integrity, and Good Documentation Practices (GDP).
• Experience supporting investigations, method validations, and equipment qualification activities preferred.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to review technical data, identify trends, and work independently with minimal supervision.
• Proficiency with laboratory software, LIMS, and Microsoft Office applications.

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 base salary for this position is $72,000 - $99,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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.

Recruitment Fraud Notice

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