Specialist, R&D Quality - 2307014737W

　　DESCRIPTION/RESPONSIBILITIES:DescriptionKenvue is currently recruiting for:Specialist, R&D Quality and Compliance

　　This position reports into Sr. Manager of R&D Quality and is based at Fort Washington, PA.

　　What You Will DoThe Specialist R&D Q&C is responsible for coordinating 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 Johnson & Johnson policies and Standard Operating Procedures. The Specialist provides documentation quality review/approval, documentation maintenance and archival, quality inspections of product. Assist in compiling documentation to release R&D studies, provides mentorship on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners, supports GMP audits, and functions as the quality lead on new product introductions/development:

　　Key Responsibilitie* Provide GMP documentation review and approval of batch records (Manufacturing, Packaging, and Labeling) and related documents, including Lab, Pilot, and Trial scale batches. Responsible for the quality inspection of supplies for R&D studies.* Assists in the preparation of the R&D Quality System Management Review (QSMR): Ensure logistic of meeting, collection of data and information, and assist management representative during the meeting by creating the meeting minutes and other documents required.* Ensures deliverables are completed in compliance to GMP regulatory requirements (including 21CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 812, 820, and Annex 13), including training of R&D personnel.* Identifies and raises quality related issues and deviations to study team and management. Participates in the generation of corrective and preventative action plans.* Ensures GMP documentation maintenance, storage, and archival process, including the daily activities supporting this process.* Contributes to the development and implementation of GMP and Quality & Compliance processes and procedures.* Supports compliance activities by participating in audit readiness; assists in Internal and External audits.

　　QualificationsWhat We Are Looking ForRequired Qualifications* Minimum of a bachelor's degree in biology, Biochemistry, Microbiology, Chemistry or related scientific field is required* At least 3-5 years of proven experience in a pharmaceutical, consumer products or FDA Regulated environment is required.* Knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices).* Ability to work and make decisions independently and on multiple projects* Ability to engage and align with other diverse and dispersed organizations and functions.* Ability to independently plan organize, coordinate, manage and complete assigned tasks* Excellent organization and time management skills, leadership skills, attention to detail, and ability to multi-task in environment with shifting priorities* Excellent knowledge of English and proficiencies in Microsoft Office applications.

　　Desired Qualifications* Experience of the overall product development process.* Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities* Proficiency in formulation or manufacturing of consumer/pharmaceutical products.* Written and oral proficiency in the English language is required* This position requires up to 10% travel based upon business needs.

　　What's In It For You * Competitive Benefit Package * Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More! * Learning & Development Opportunities * Employee Resource Groups

　　Kenvue is proud to be an Equal Opportunity Employer. All ualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.