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Manager I, Quality Control

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Baxter

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Location:
United States , Hayward

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

112000.00 - 154000.00 USD / Year
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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
  • 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
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

Additional Information:

Job Posted:
April 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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