QA Specialist, Aseptic Manufacturing Oversight

americanregent; 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

Wide range of other benefits

Job summary

American Regent in Shirley, NY seeks a QA Specialist, Aseptic Manufacturing Oversight to ensure GMP compliance in aseptic areas and provide real-time quality oversight through video monitoring and rapid guidance.

You will identify issues, support CAPA and trending, and collaborate with quality and operations to sustain compliant production while promoting a strong quality culture.

Qualifications

• Bachelor's degree in Science or Engineering required or equivalent experience.
• 2–5 years' pharmaceutical industry experience including aseptic manufacturing.
• Must become gown qualified for APA presence.
• Strong knowledge of Quality Systems and cGMP with ability to assess compliance risks.
• Excellent verbal, written, and interpersonal communication skills.

Responsibilities

• Perform in person APA oversight with gown qualification maintenance.
• Conduct APA video reviews (gowning, cleaning, filling, environmental monitoring) live or retrospective.
• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
• Elevate major/critical video observations to shop-floor or supervision for review.
• Assist with development and delivering training on aseptic manufacturing behaviors.

Skills

Quality systems knowledge

cGMP knowledge

Attention to detail

Communication skills

Time management

Team collaboration

Conflict resolution

Education

Bachelor's degree in Science or Engineering

Job description

Nature and Scope

The QA Specialist, Aseptic Manufacturing Oversight ensures that American Regent operates in compliance with all applicable procedures and regulations. This role provides real-time quality oversight in aseptic manufacturing areas to ensure operations meet GMP, regulatory, and site quality standards. This role delivers immediate support, promotes a strong quality culture, and partners with operations and quality staff to achieve production goals while maintaining compliance. Responsibilities include proactive issue identification, timely decision support, and reinforcing high standards of quality and compliance. The role is responsible for providing oversight for Aseptic Processing Area (APA) in relation to aseptic practices and behaviors, including direct video monitoring of aseptic manufacturing. The role also supports training, metrics, trending and investigations related to aseptic behaviors and practices.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Perform in person APA oversight as assigned. Requires gown qualification maintenance.
• Perform APA video review, including but not limited to, gowning, APA cleaning, filling room set-up, filling activities, and environmental monitoring. Video review may be required to be performed live or retrospectively.
• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
• Identify and elevate 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 appropriately categorize observations from video review as per procedure and/or protocol.
• Document video review performance and observations as per procedure and/or protocol.
• Assist with video review of Environmental Monitoring and Personnel Monitoring events, as assigned.
• 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.
• Consistently perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Communicate with tact and consideration for feedback to remain constructive.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• Bachelor's degree in a Science or Engineering field, required. Equivalent years of experience to be considered.
• 2-5 years' experience within the pharmaceutical industry including aseptic manufacturing required.
• Demonstrate ability to become and remain gown qualified for APA presence, required.
• Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Demonstrate ability to perform detail-oriented work with a high degree of accuracy.
• Excellent verbal, written, and interpersonal communication skills.
• Effective time management and collaboration skills.
• Strong organizational skills, planning skills and must work effectively within teams.
• Ability to resolve conflicts and disagreements on regulatory compliance issues.

Physical Environment and Requirements

• May have to wear protective clothing in the laboratories and manufacturing areas for access as required for safety and product controls.

Expected Salary Range:

$70,100 - 80,000

American Regent also offers a competitive total rewards package.

• healthcare
• life insurance
• profit sharing
• paid time off
• matching 401k
• wide range of other benefits

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive cons