Aseptic Manufacturing QA Oversight Specialist

American Regent, Inc.; Shirley (NY); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

401k matching

Other benefits

Job summary

American Regent, Inc. in New York is seeking a QA Specialist, Aseptic Manufacturing Oversight to ensure GMP compliance and real-time quality monitoring in aseptic processes.

You will oversee APA practices, review video footage, and support training, CAPA activities, and trend analysis across operations. The role requires a Bachelor's in Science/Engineering, 2-5 years in pharma with aseptic manufacturing, and gown-qualified status, with strong communication and teamwork skills.

Qualifications

• Bachelor’s degree in Science or Engineering is required.
• 2–5 years of pharmaceutical industry experience including aseptic manufacturing.
• Must maintain APA gown qualification and demonstrate cGMP knowledge.
• Strong attention to detail and effective communication skills.
• Ability to work collaboratively in cross-functional teams.

Responsibilities

• Perform in-person APA oversight as assigned.
• Maintain gown qualification for APA presence.
• Perform APA video review, including gowning, cleaning, room setup, filling activities, and environmental monitoring.
• Provide GMP and aseptic behavior guidance to operators and supervisors.
• Elevate major observations to shop floor or management as appropriate.
• Document video reviews and observations per procedures.
• Assist with trending and CAPA development related to aseptic practices.
• Support training on aseptic manufacturing behaviors and practices.
• Review and approve deviation investigations and CAPAs.
• Participate in cross-functional project teams and suggest improvements.

Skills

Gown qualification maintenance

cGMP knowledge

Attention to detail

Communication skills

Team collaboration

Education

Bachelor’s degree in Science or Engineering

Job description

American Regent, Inc. in New York is seeking a QA Specialist, Aseptic Manufacturing Oversight to ensure GMP compliance and real-time quality monitoring in aseptic processes.

You will oversee APA practices, review video footage, and support training, CAPA activities, and trend analysis across operations. The role requires a Bachelor's in Science/Engineering, 2-5 years in pharma with aseptic manufacturing, and gown-qualified status, with strong communication and teamwork skills.