QA Specialist, Aseptic Manufacturing Oversight

American Regent, Inc.; Shirley (NY); Hybrid; 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 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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Detail-oriented

Communication skills

Quality oversight

Video review operations

Education

Bachelor’s degree in Science or Engineering

Equivalent years of experience in pharmaceutical industry

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 expedite 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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

Expected Salary Range: $70,100 - $80,000

Benefits

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

Equal Opportunity & Diversity

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 consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

Regulatory Resources

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlan.pdf

Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Contact and Accessibility

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].

Our Values and Company Overview

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.

Company Details

American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs.

We have locations in New York, Ohio, and California and sales territories nationwide.