Aseptic QA Oversight Specialist

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

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

401k with matching

Paid time off

Job summary

American Regent is seeking a QA Specialist for Aseptic Manufacturing Oversight in Shirley, NY. You will provide real-time quality oversight in aseptic areas, ensuring GMP compliance and supporting operations to meet production goals while upholding high quality standards.

The role involves video review of aseptic practices, training, CAPA development, and collaboration with cross-functional teams to sustain a strong quality culture. Strong detail orientation and communication are essential.

Qualifications

• Bachelor’s degree in Science or Engineering.
• 2–5 years’ experience in pharmaceutical industry.
• Gown qualification for APA presence.
• Strong knowledge of cGMP (FDA/EU/ICH).
• Excellent verbal and written communication.
• Ability to work in teams and manage time.

Responsibilities

• Perform in person APA oversight as assigned and maintain gown qualification.
• Conduct APA video review (gowning, APA cleaning, filling room setup, filling activities, environmental monitoring).
• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
• Identify and escalate major and critical observations from video review.
• Document video review performance and observations per procedure.
• Assist with video review of Environmental Monitoring and Personnel Monitoring events.
• Assist with trending and tracking video review observations for CAPA development.
• Assist with development and delivery of training related to aseptic manufacturing behaviors and practices.
• Review and approve deviation investigations and CAPAs.
• Participate in cross-functional project teams.
• Recommend improvements to procedures and processes.

Skills

Quality systems

cGMP knowledge

Communication skills

Time management

Team collaboration

Attention to detail

Education

Bachelor’s degree in Science or Engineering

Job description

American Regent is seeking a QA Specialist for Aseptic Manufacturing Oversight in Shirley, NY. You will provide real-time quality oversight in aseptic areas, ensuring GMP compliance and supporting operations to meet production goals while upholding high quality standards.

The role involves video review of aseptic practices, training, CAPA development, and collaboration with cross-functional teams to sustain a strong quality culture. Strong detail orientation and communication are essential.