Aseptic QA Specialist: Real-Time Manufacturing Oversight

American Regent

Shirley (NY)

On-site

USD 70,000 - 80,000

Full time

3 days ago

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Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

401k match

Job summary

American Regent is seeking a QA Specialist, Aseptic Manufacturing Oversight, to ensure adherence to GMP and site quality standards in aseptic areas. You will provide real-time quality oversight, support operators and supervise video reviews of APA activities, and help maintain a strong quality culture.

Responsibilities include identifying issues, escalating observations, supporting CAPA development, and contributing to training on aseptic behaviors.

Qualifications

Bachelor's degree in a Science or Engineering field.
2-5 years’ experience in pharmaceutical aseptic manufacturing.
Gown qualified for APA presence.
Strong knowledge of Quality Systems and cGMP.

Responsibilities

Perform in person APA oversight with gown qualification maintenance.
Conduct APA video review of gowning, cleaning, filling room setup and environments.
Provide immediate GMP and aseptic behavior guidance to operators.
Identify and escalate major observations from video review to shop-floor or management.
Document video review observations per procedures and assist CAPA development.
Assist training and cross-functional project teams on aseptic practices.