Quality Specialist 2

1 week ago

Summit, United States Katalyst HealthCares & Life Sciences Full time

Job Description: The Specialist R&D Quality & Compliance (R&D Q&C) is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP), and within Kenvue policies and Standard Operating Procedures. The Specialist is responsible for participating on documentation quality review/approval of R&D Sales Samples and R&D Product Quality Complaints (PQCs). In addition to these tasks, supporting documentation maintenance and archival, quality inspections of R&D products, and in internal assessments on R&D processes specific to GxP. The Specialist must be knowledgeable to provide guidance on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners. Responsibilities: Participate in GMP documentation review and approval of sales samples including identifying opportunities to optimize release processes for agility and speed to customer sales teams. Participate in working with various functional groups, as needed, to conduct problem identification and resolution along with assisting in compiling documentation to review and approve assessments and/or investigations for R&D Product Quality Complaints (PQC). Support in the development and implementation of GMP and Quality & Compliance processes and procedures including supporting GMP documentation review and approval. Support on internal assessments of R&D GMP processes and areas and identify opportunities to streamline. Support in inspection readiness activities. Support quality inspection of supplies for R&D studies. Requirements: Experience of the overall product development process. Problem solver (proactive in providing and executing solutions). Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities. Working knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various. product classification types (cosmetic, OTC/OTC Monograph and Medical Devices). Ability to Independently plan, organize, co-ordinate, manage, and execute assigned tasks. Ability to work collaboratively in team environments. Written and oral proficiency in the English language. Strong communicator with excellent interpersonal skills and diplomacy. Good conflict handling/negotiation skills.

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