Aseptic QA Specialist: Real-Time Oversight & CAPA

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

Job summary

American Regent, Inc. is seeking a QA Specialist, Aseptic Manufacturing Oversight to provide real-time quality oversight in aseptic areas and ensure GMP compliance. You will oversee APA activities, participate in video reviews, and support CAPA investigations and training.

Requires gown qualification and 2–5 years pharma experience with strong regulatory knowledge. The role collaborates with operations and quality staff to maintain high standards and a strong quality culture.

Qualifications

• Bachelor’s degree in a Science or Engineering field is required.
• 2–5 years’ experience within the pharmaceutical industry including aseptic manufacturing.
• Gown qualified for APA presence is required.
• Strong knowledge of Quality Systems and cGMP (FDA, EU, ICH).
• Detail-oriented with high accuracy.
• Excellent verbal and written communication skills.
• Time management and collaboration skills.
• Organizational skills and teamwork.
• Ability to resolve regulatory compliance issues.

Responsibilities

• Perform in person APA oversight as assigned. Requires gown qualification maintenance.
• Perform APA video review, including gowning, cleaning, filling room setup, filling activities, and environmental monitoring.
• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
• Identify and escalate major and critical observations identified during video review to shop-floor immediately in case of live video review, and to supervision/management for retrospective video review.
• Evaluate and categorize observations from video review per procedure and/or protocol.
• Document video review performance and observations per procedure and/or protocol.
• Assist with video review of Environmental Monitoring and Personnel Monitoring events.
• Assist with trending and tracking of video review observations to aid in CAPA development.
• Assist with development and delivering training related to aseptic manufacturing behaviors and practices.
• Review and approval of deviation investigations and CAPAs.
• Actively participate in cross-functional project teams.
• Collaborate with colleagues to achieve desired outcomes.
• Make recommendations for improvements to procedure and processes.
• Keep informed about current good industry practices and recommend areas of improvement.
• Perform any other tasks/duties as assigned by management.

Skills

Gown qualified

Video review

GMP compliance

Regulatory knowledge

Communication skills

Education

Bachelor’s degree in Science or Engineering

Job description

American Regent, Inc. is seeking a QA Specialist, Aseptic Manufacturing Oversight to provide real-time quality oversight in aseptic areas and ensure GMP compliance. You will oversee APA activities, participate in video reviews, and support CAPA investigations and training.

Requires gown qualification and 2–5 years pharma experience with strong regulatory knowledge. The role collaborates with operations and quality staff to maintain high standards and a strong quality culture.