Integrated Quality Assurance Inspector V

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make In this role, you will be responsible for overseeing the quality of equipment and material preparation, as well as aseptic compounding, filling, and inspection activities. Supporting site-wide objectives, you will coordinate support activities, review and audit semi-finished product manufacturing and testing documentation, and ensure that all released products comply with regulatory and cGMP requirements. The IQI collaborates with cross-functional teams to drive continuous improvement initiatives, support incident investigations, and implement necessary changes. This position requires strong decision-making abilities related to incident investigations and corrective and preventive actions, with a focus on overall quality, site priorities, and performance outcomes. ROLE RESPONSIBILITIES Responsible for reviewing documents to ensure the manufacturing and testing processes adhered to the approved batch/testing record and are compliant with approved SOP’s and cGMPs. Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation review Proactively identify and address non-conformances in manufacturing operations Performs timely reviews and determines batch acceptability and product disposition. Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.    Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations. Alert management promptly to any issues identified during batch record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards. Review and edit SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures. Participates in internal GMP audits and supports customer and regulatory audits. Assists in review and editing of SOPs / Master Batch Records.   BASIC QUALIFICATIONS Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline. 2 years of experience in the pharmaceutical industry. Experience in Batch Record Review/Audit/Disposition Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex). Independently consistently produces quality work. Works in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Collects, researches, analyzes, and presents data information skillfully. Certified Quality Auditor (CQA) Certification preferred.   PHYSICAL QUALIFICATIONS Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site. Must have the ability to work effectively under and manage to strict production, time, and performance deadlines. Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may occasionally include weekends and holidays. #LI-Onsite