Aseptic QA Oversight Specialist, 3rd Shift

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

Job summary

American Regent, Inc. is seeking a QA Specialist for Aseptic Manufacturing Oversight on the 3rd shift (11pm-7:30am) in Shirley, NY. The role provides real-time quality oversight in aseptic areas, supporting GMP compliance and quality standards while partnering with operations and quality teams.

Responsibilities include video review, live or retrospective, issue escalation, and CAPA development. Requires a Science/Engineering degree and 2–5 years in pharma with gown qualification and strong

Qualifications

• Bachelor’s degree in a Science or Engineering field is required or equivalent experience.
• 2–5 years of pharmaceutical industry experience including aseptic manufacturing.
• Must be gown qualified for APA presence and have knowledge of aseptic practices.
• Solid understanding of quality systems and current Good Manufacturing Practice (cGMP).
• Strong written and verbal communication skills with good organizational ability.

Responsibilities

• Provide real-time quality oversight of aseptic manufacturing and APA video review.
• Offer immediate GMP guidance and escalate critical observations to leadership.
• Document observations and assist with CAPA development and investigations.
• Assist with training related to aseptic manufacturing behaviors and practices.
• Collaborate with operations and quality staff to ensure compliance and production goals.

Skills

Gown qualification

Aseptic manufacturing

GMP knowledge

cGMP compliance

Video review

Issue identification

Cross-functional collaboration

Quality systems

Exceptional attention to detail

Verbal and written communication

Education

Bachelor’s degree in Science or Engineering

Job description

American Regent, Inc. is seeking a QA Specialist for Aseptic Manufacturing Oversight on the 3rd shift (11pm-7:30am) in Shirley, NY. The role provides real-time quality oversight in aseptic areas, supporting GMP compliance and quality standards while partnering with operations and quality teams.

Responsibilities include video review, live or retrospective, issue escalation, and CAPA development. Requires a Science/Engineering degree and 2–5 years in pharma with gown qualification and strong