Quality Manager I - Microbiology at Baxter
Marion, North Carolina, USA -
Full Time


Start Date

Immediate

Expiry Date

16 Nov, 25

Salary

154000.0

Posted On

16 Aug, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

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.

Responsibilities

WHAT YOU’LL BE DOING

  • Develop a team of supervisors and/or department leads involved in microbiology testing of raw materials and finished good products.
  • Supervise product testing procedures for bioburden, microbial identification, endotoxin, and solution particulate matter.
  • Ensure compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and other relevant regulations and standards.
  • Coordinate with cross-functional teams to address testing requirements and timelines in support of change controls, protocols, and engineering studies.
  • Collaborate with Quality Assurance to achieve timely resolution of deviations, investigations, and corrective actions related to areas of responsibility.
  • Participate in internal and external audits, including direct interfacing with regulatory agencies such as FDA.
  • Remain informed about industry trends, regulatory changes, and emerging technologies related to microbiology testing.
  • Develop, maintain, and establish action plans as needed for Key Performance Indicators (KPIs) and Metrics to maintain and improve the efficiency and effectiveness of product testing processes.
  • Identify and lead continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
  • Develops and ensures adherence to budget and reports on overspend as necessary to evaluate reason and possible corrections.
  • Manages the coaching, training and development process of subordinates.
  • Sustain a clean and safe work area using 6S principles.
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