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Manager I, Quality Control

United States, Hayward Employment contract 112000.00 - 154000.00 USD / Year · Job Posted May 29, 2026
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Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

  • Manage the activities of the Quality Control Laboratory organization with responsibility for testing and review of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and real-time stability testing
  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSMR, cGMP, USP, and ISO rules, and guidelines), develop policies/procedures to implement these requirements for the laboratory operations
  • Ensure compliance with testing SOPs and specifications. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab
  • Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support
  • Manage operating budget for the laboratory
  • Monitor the testing techniques & accuracy of all records & documentation that is done in the lab
  • Ensure completion of all testing, including special project/protocol testing in a timely & appropriate manner
  • Assure equipment maintenance & calibration, and internal audits are performed on schedule
  • Prepare, review & revise, as required, SOPs & specifications. Write memos, reports, protocols, & other appropriate documentation for proper functioning of the lab operation
  • Provide necessary support related to Non-Conformity Reports, Validations, Change Controls, Out of specifications, Out of trends, Laboratory Error Reports, Risk assessments, Impact assessments, market complaints and relevant CAPA's
  • Support Laboratory investigations, Non-conformance/Exceptions and corrective/preventative actions and change controls as required
  • Assure compliance with company procedures. Prepare the department ready for an audit by both internal and external authorities. Serve as the Quality Management for the lab. and interface with investigators during these inspections
  • Participates in management reviews of process performance, product quality advocating continual improvement within area of operations
  • Ensure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and insure employees have development plans
  • Manage personnel functions including interviewing, hiring, performance appraisals, promotions, transfers & vacation schedules
  • Work with teams of business units and meet operational goals
  • Assure a safe and non-discriminatory working environment for employees.

Requirements

  • Bachelor’s degree in Chemistry, Biological Science or related field
  • 5+ years’ experience in Quality Control with experience in chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization or real-time stability testing
  • 2+ years of supervisory experience
  • Strong understanding of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and/or real-time stability testing
  • Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs
  • Must have the ability of managing complex projects and resolving complex lab Issues
  • Must possess excellent supervisory and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities
  • Should have advanced knowledge in Statistical Analysis, QSMR, cGMP, CFR, USP GDP and ISO
  • Strong leadership, project and people management skills, and ability to make critical decisions
  • Strong understanding of business and/or industry
  • 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.

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • educational assistance programs
  • paid holidays
  • paid time off ranging from 20 to 35 days based on length of service
  • family and medical leaves of absence
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits

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Manager I, Quality Control

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Manager I, Quality Control

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Hayward
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Chemistry, Biological Science or related field
  • 5+ years’ experience in Quality Control with experience in chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization or real-time stability testing
  • 2+ years of supervisory experience
  • Strong understanding of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and/or real-time stability testing
  • Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs
  • Must have the ability of managing complex projects and resolving complex lab Issues
  • Must possess excellent supervisory and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities
  • Should have advanced knowledge in Statistical Analysis, QSMR, cGMP, CFR, USP GDP and ISO
  • Strong leadership, project and people management skills, and ability to make critical decisions
  • Strong understanding of business and/or industry
Job Responsibility
Job Responsibility
  • Manage the activities of the Quality Control Laboratory organization with responsibility for testing and review of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and real-time stability testing
  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSMR, cGMP, USP, and ISO rules, and guidelines), develop policies/procedures to implement these requirements for the laboratory operations
  • Ensure compliance with testing SOPs and specifications
  • Monitor the testing techniques and accuracy of all records and documentation that is done in the lab
  • Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support
  • Manage operating budget for the laboratory
  • Monitor the testing techniques & accuracy of all records & documentation that is done in the lab
  • Ensure completion of all testing, including special project/protocol testing in a timely & appropriate manner
  • Assure equipment maintenance & calibration, and internal audits are performed on schedule
  • Prepare, review & revise, as required, SOPs & specifications
What we offer
What we offer
  • Medical and dental coverage
  • Basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • Paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Fulltime
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Arrow Right

Manager I, Quality Control

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Hayward
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Chemistry, Biological Science or related field
  • 5+ years’ experience in Quality Control with experience in chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization or real-time stability testing
  • 2+ years of supervisory experience
  • Strong understanding of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and/or real-time stability testing
  • Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs
  • Must have the ability of managing complex projects and resolving complex lab Issues
  • Must possess excellent supervisory and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities
  • Should have advanced knowledge in Statistical Analysis, QSMR, cGMP, CFR, USP GDP and ISO
  • Strong leadership, project and people management skills, and ability to make critical decisions
  • Strong understanding of business and/or industry
Job Responsibility
Job Responsibility
  • Manage the activities of the Quality Control Laboratory organization with responsibility for testing and review of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and real-time stability testing
  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSMR, cGMP, USP, and ISO rules, and guidelines), develop policies/procedures to implement these requirements for the laboratory operations
  • Ensure compliance with testing SOPs and specifications
  • Monitor the testing techniques and accuracy of all records and documentation that is done in the lab
  • Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support
  • Manage operating budget for the laboratory
  • Monitor the testing techniques & accuracy of all records & documentation that is done in the lab
  • Ensure completion of all testing, including special project/protocol testing in a timely & appropriate manner
  • Assure equipment maintenance & calibration, and internal audits are performed on schedule
  • Prepare, review & revise, as required, SOPs & specifications
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
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Manager I, Quality Control

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Hayward
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Chemistry, Biological Science or related field
  • 5+ years’ experience in Quality Control with experience in chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization or real-time stability testing
  • 2+ years of supervisory experience
  • Strong understanding of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and/or real-time stability testing
  • Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs
  • Must have the ability of managing complex projects and resolving complex lab Issues
  • Must possess excellent supervisory and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities
  • Should have advanced knowledge in Statistical Analysis, QSMR, cGMP, CFR, USP GDP and ISO
  • Strong leadership, project and people management skills, and ability to make critical decisions
  • Strong understanding of business and/or industry
Job Responsibility
Job Responsibility
  • Manage the activities of the Quality Control Laboratory organization with responsibility for testing and review of chemistry, environmental monitoring, microbiological (e.g., pyrogen, bioburden), sterilization and real-time stability testing
  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSMR, cGMP, USP, and ISO rules, and guidelines), develop policies/procedures to implement these requirements for the laboratory operations
  • Ensure compliance with testing SOPs and specifications
  • Monitor the testing techniques and accuracy of all records and documentation that is done in the lab
  • Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support
  • Manage operating budget for the laboratory
  • Ensure completion of all testing, including special project/protocol testing in a timely & appropriate manner
  • Assure equipment maintenance & calibration, and internal audits are performed on schedule
  • Prepare, review & revise, as required, SOPs & specifications
  • Write memos, reports, protocols, & other appropriate documentation for proper functioning of the lab operation
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
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  • Current Department of Defense secret security clearance or higher required
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Job Responsibility
Job Responsibility
  • Administer and implement the quality control system as outlined in the quality control manual for the project
  • Identify and resolve quality control issues, ensuring transparency in communication regarding deficiencies
  • Liaise with clients, regulatory agencies, and subcontractors on quality-related matters
  • Perform inspections and testing of materials, equipment, and workmanship, documenting results accurately
  • Maintain and review construction documentation, ensuring compliance with contract specifications
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  • Medical (100% Company Paid Premium)
  • Dental
  • Vision insurance
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  • Excellent written and verbal communication skills with the ability to present information clearly
  • Strong proficiency in Microsoft Office Suite and web-based tools
  • Minimum of a high school diploma/GED with at least 10 years of experience in quality control or project management
  • a four-year degree in engineering or construction management is preferred
  • Current Department of Defense secret security clearance or higher required
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  • Physical ability to perform duties in various construction settings, including working in confined spaces and at heights, as well as maintaining safety protocols
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  • Administer and implement the quality control system as outlined in the quality control manual for the project
  • Identify and resolve quality control issues, ensuring transparency in communication regarding deficiencies
  • Liaise with clients, regulatory agencies, and subcontractors on quality-related matters
  • Perform inspections and testing of materials, equipment, and workmanship, documenting results accurately
  • Maintain and review construction documentation, ensuring compliance with contract specifications
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  • 401k w/ 8% match
  • 4 weeks PTO
  • Company focus on employee growth & development
  • Completion bonus
  • Housing provided/paid for
  • Monthly incidentals
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