Description
Overview
The contractor will provide temporary QA support to maintain quality and compliance oversight of sterile pharmaceutical products manufactured by third-party partners. The focus will be on batch release, issue resolution, and regulatory compliance for the duration of the assignment. This role will ensure continuity in QA oversight without disruption to supply or compliance commitments.
Responsibilities
Core Responsibilities
Review manufacturing and packaging batch records; escalate issues and perform final disposition of assigned products.
Support and coordinate investigations (deviations, OOS/OOT, product complaints), initiate CAPAs, and ensure timely closure.
Maintain ongoing communication with contract manufacturers to resolve quality issues, monitor compliance, and ensure product release readiness.
Provide QA input during regulatory inspections and support documentation needs (change controls, stability protocols, technical agreements).
Assist in ensuring that audit findings are tracked and CAPAs are effectively implemented.
Collaborate with Supply Chain, Regulatory, and other partners to ensure continued product quality and supply continuity.
Lead large-scale technology transfers.
Build or negotiate new or existing quality agreements.
Provide support for Shionogi Developmental Products as needed
Minimum Requirements
Minimum 4 years of experience of QA experience in sterile drug product manufacturing/oversight.
Strong background in batch record review, CAPA management, and sterility assurance.
Direct experience with third-party (CMO) oversight.
Able to operate independently with minimal supervision.
Comfortable working cross-functionally and representing QA in external partner interactions.
Experience with quality management software and tools such as Veeva including demonstrated computer experience with MS Word, Excel, and Outlook.
Strong knowledge of regulatory requirements and guidelines, such as FDA, EMA, MHRA, PIC/S, ICH, and sterility assurance standards.
Ability to work 50% of the time a month at Florham Park, NJ corporate office.
Additional Information
The hourly rate for this position is $49 - $59. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, applicable allowances, or any additional compensation that may be associated with this role.
EEO
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.