Aseptic QA Oversight Specialist

American Regent, Inc.; Shirley (NY); Hybrid; USD 70.000 - 80.000; Vollzeit

Benefits dieser Stelle

Healthcare

Life Insurance

Profit Sharing

Paid Time Off

401k Matching

Zusammenfassung

American Regent, Inc. is seeking a QA Specialist, Aseptic Manufacturing Oversight to ensure GMP compliance in aseptic areas and provide real-time quality oversight across operations. You will collaborate with operations and quality staff to maintain high standards and support production goals.

The role includes routine video review of aseptic practices, gown qualification maintenance, training support, and involvement in investigations, CAPAs, trending, and continuous improvement initiatives.

Qualifikationen

• Bachelor’s degree in Science or Engineering required.
• 2-5 years’ experience in the pharmaceutical industry including aseptic manufacturing required.
• Must remain gown qualified for APA presence.
• Strong knowledge of cGMP requirements (FDA, EU, ICH) and risk assessment capability.

Aufgaben

• Perform in person APA oversight as assigned.
• Perform APA video review of gowning, cleaning, room setup, filling activities, and environmental monitoring.
• Provide GMP and aseptic behavior guidance to operators and supervisors.
• Identify and escalate observations from video reviews to shop-floor and management as needed.
• Assist with training related to aseptic manufacturing behaviors and practices.

Kenntnisse

Detail-oriented

Communication skills

Quality oversight

Video review operations

Ausbildung

Bachelor’s degree in Science or Engineering

Equivalent years of experience in pharmaceutical industry

Jobbeschreibung

American Regent, Inc. is seeking a QA Specialist, Aseptic Manufacturing Oversight to ensure GMP compliance in aseptic areas and provide real-time quality oversight across operations. You will collaborate with operations and quality staff to maintain high standards and support production goals.

The role includes routine video review of aseptic practices, gown qualification maintenance, training support, and involvement in investigations, CAPAs, trending, and continuous improvement initiatives.