Aseptic Quality & Contamination Control Strategy Lead

Simtrabps; Bloomington (IN); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Paid Time Off

Education Assistance Program

Job summary

Simtrabps, located in Bloomington, Indiana, is seeking a Sr Manager Quality to establish and improve contamination control strategies for sterile injectable manufacturing. The candidate will drive compliance with regulations and lead aseptic practices across the facility.

This role requires a strong background in microbiology, significant leadership experience, and a commitment to quality and safety. Candidates should hold a Bachelor's degree in Microbiology or a related field, with preferred Master's level education. Full benefits and opportunities for professional development are provided.

Qualifications

• 8+ years in sterile pharmaceutical manufacturing or QC microbiology/QA roles.
• At least 5 years in SME capacity related to contamination control.
• Strong knowledge of regulatory standards (EU GMP, FDA).

Responsibilities

• Owns the aseptic observer program and oversees cleanroom behavior.
• Leads development of the Contamination Control Strategy (CCS).
• Prepares and presents data to site and executive leadership.

Skills

Regulatory inspection participation

Microbiological oversight

Leadership in aseptic processing

Strong communication and writing skills

Education

Bachelors degree in Microbiology or related science

Masters degree in Microbiology or Pharmaceutical Sciences

Job description

Simtrabps, located in Bloomington, Indiana, is seeking a Sr Manager Quality to establish and improve contamination control strategies for sterile injectable manufacturing. The candidate will drive compliance with regulations and lead aseptic practices across the facility.

This role requires a strong background in microbiology, significant leadership experience, and a commitment to quality and safety. Candidates should hold a Bachelor's degree in Microbiology or a related field, with preferred Master's level education. Full benefits and opportunities for professional development are provided.