QA Specialist, Aseptic Manufacturing Oversight

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. It delivers immediate support, promotes a strong quality culture, and partners with operations and quality staff to achieve production goals while maintaining compliance.

Responsibilities

• Perform in-person Aseptic Processing Area (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 live or retrospective.
• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.
• Identify and escalate major and critical observations from video review to the shop-floor (live) or to supervision/management (retrospective).
• Evaluate and categorize observations from video review 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 delivery of training related to aseptic manufacturing behaviors and practices.
• Review and approve deviation investigations and CAPAs.
• Actively participate in cross-functional project teams.
• Collaborate with colleagues to achieve desired outcomes.
• Make recommendations for improvements to procedures 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/industry regulatory guidelines.
• Communicate with tact and consideration for feedback to remain constructive.
• Perform any other tasks/duties as assigned by management.

Requirements

• Bachelor’s degree in a Science or Engineering field, required. Equivalent years of experience may be considered.
• 2-5 years’ experience within the pharmaceutical industry, including aseptic manufacturing.
• Demonstrated ability to become and remain gown qualified for APA presence.
• Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Demonstrated 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; must work effectively within teams.
• Ability to resolve conflicts and disagreements on regulatory compliance issues.

Physical Environment

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

Pay

Expected salary range: $70,100 - $80,000. Actual compensation will be based on candidate’s qualifications, education, knowledge, skills, and experience.

Benefits

• Healthcare and life insurance
• Profit sharing
• Paid time off
• Matching 401k
• Wide range of additional benefits