Aseptic QA Manager: Sterility Oversight

American Regent, Inc.; Shirley (NY); On-site; USD 118,000 - 137,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

401(k) matching

Job summary

American Regent, Inc. is seeking a QA Manager, Aseptic Manufacturing Oversight to ensure compliance with procedures and regulations across the APA. The role includes direct management of Sterility Assurance and video monitoring staff with full signatory authority for quality matters.

Responsibilities include oversight of media fills, environmental monitoring, risk assessments, and cGMP documentation, while collaborating with operations and engineering to drive compliance and improvements.

Qualifications

• Bachelor’s degree, required.
• 5+ years in GMP oversight with 1-3 years of people management experience.
• Minimum of 5 years of sterility assurance or microbiology experience within pharmaceutical aseptic manufacturing.
• Strong knowledge of cGMP requirements (FDA, EU, ICH).
• Ability to travel domestically and internationally up to 10%.

Responsibilities

• Oversee qualification and requalification of APA personnel to ensure aseptic competency and compliance.
• Provide oversight of video monitoring programs for aseptic operations and follow-up of observations.
• Oversee media fill planning, execution, and post-execution assessment to verify aseptic process control.
• Review Environmental Monitoring and Personnel Monitoring results and investigate excursions.
• Lead lifecycle risk assessments and mitigation for aseptic processing activities.

Skills

GMP knowledge

Quality systems

People management

Regulatory liaison

Analytical thinking

Communication skills

Education

Bachelor’s degree

Tools

Isolator technology

Job description

American Regent, Inc. is seeking a QA Manager, Aseptic Manufacturing Oversight to ensure compliance with procedures and regulations across the APA. The role includes direct management of Sterility Assurance and video monitoring staff with full signatory authority for quality matters.

Responsibilities include oversight of media fills, environmental monitoring, risk assessments, and cGMP documentation, while collaborating with operations and engineering to drive compliance and improvements.