Senior Microbiology Quality Leader

NCBioImpact; Marion (NC); On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with company match

Paid time off 20–35 days

Job summary

Baxter is seeking a Sr. Manager - Microbiology to lead the microbiology testing and quality assurance across raw materials and finished products.

You will supervise bioburden, endotoxin and ID testing, ensuring GMP/GLP adherence, and coordinating with cross-functional teams to meet change controls and engineering studies. You will drive audits and continuous improvement while mentoring staff and ensuring timely investigations and corrective actions.

Qualifications

• Bachelor's degree in Science, Biology or Microbiology.
• 10+ years in Quality, Manufacturing, Engineering or related field.
• 7+ years in a cGMP related industry.
• 5+ years leadership in aseptic or sterile manufacturing.
• Knowledge of microbiology testing: bioburden, endotoxin, particulates, ID.
• Familiar with USP, FDA, ISO standards.
• Strong leadership, communication and interpersonal skills.

Responsibilities

• Develop and lead a team of supervisors/department leads for microbiology testing of raw materials and finished products.
• Supervise product testing procedures for bioburden, endotoxin, particulates and microbial ID.
• Ensure GMP/GLP compliance and other relevant regs.
• Coordinate with cross-functional teams on testing requirements and change controls.
• Collaborate with QA to resolve deviations, investigations and corrective actions.
• Participate in audits and interface with regulatory agencies such as FDA.
• Stay informed on regulatory changes and tech advances in microbiology testing.
• Develop and monitor KPI/metrics to improve testing efficiency and quality.
• Lead continuous improvement projects for quality, reliability and cost.
• Develop and manage budget and report overspend; coach/subordinate development.
• Maintain a clean, safe work area following 6S principles.

Skills

Leadership

GMP/GLP knowledge

Regulatory awareness

Analytical skills

Education

Bachelor's degree in Science (Biology or Microbiology)

Job description

Baxter is seeking a Sr. Manager - Microbiology to lead the microbiology testing and quality assurance across raw materials and finished products.

You will supervise bioburden, endotoxin and ID testing, ensuring GMP/GLP adherence, and coordinating with cross-functional teams to meet change controls and engineering studies. You will drive audits and continuous improvement while mentoring staff and ensuring timely investigations and corrective actions.