QA Specialist, Aseptic Manufacturing Oversight 3rd Shift (11pm-7:30am)

American Regent•Shirley, NY

18d

About The Position

The QA Specialist, Aseptic Manufacturing Oversight ensures American Regent operates in compliance with applicable procedures and regulations. The role provides real-time quality oversight in aseptic manufacturing areas to help ensure operations meet GMP, regulatory, and site quality standards. It provides immediate support, promotes a strong quality culture, and partners with operations and quality staff to achieve production goals while maintaining compliance. The position oversees the Aseptic Processing Area (APA) for aseptic practices and behaviors, including direct video monitoring of aseptic manufacturing. It also supports training, metrics, trending, and investigations related to aseptic behaviors and practices. The role requires in-person APA oversight as assigned and maintenance of gown qualification. The employee may need to wear protective clothing in laboratories and manufacturing areas for safety and product controls.

Requirements

Bachelor's degree in a Science or Engineering field, or equivalent years of experience.
2–5 years of experience within the pharmaceutical industry, including aseptic manufacturing.
Ability to become and remain gown qualified for APA presence.
Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements, including FDA, EU, and ICH requirements, and ability to assess compliance risks.
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 and planning skills, with the ability to work effectively within teams.
Ability to resolve conflicts and disagreements on regulatory compliance issues.

Responsibilities

Perform in-person APA oversight as assigned and maintain gown qualification.
Review APA video, including gowning, APA cleaning, filling room setup, filling activities, and environmental monitoring; reviews may be live or retrospective.
Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
Identify and escalate major and critical observations from live video review to the shop floor immediately, and escalate retrospective-review observations to supervision or management.
Evaluate and categorize video-review observations according to applicable procedures or protocols.
Document video-review performance and observations according to applicable procedures or protocols.
Assist with video review of Environmental Monitoring and Personnel Monitoring events as assigned.
Assist with trending and tracking video-review observations to support CAPA development.
Assist with developing and delivering training on aseptic manufacturing behaviors and practices.
Review and approve deviation investigations and CAPAs.
Participate in cross-functional project teams and collaborate with colleagues to achieve desired outcomes.
Recommend improvements to procedures and processes.
Stay informed about current good industry practices and recommend areas for improvement.
Perform duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and applicable government and industry regulatory guidelines.
Communicate constructively, with tact and consideration for feedback.
Perform other tasks and duties as assigned by management.