Quality Systems Specialist II - 2407024270W

Quality Systems Specialist II - 2407024270W DESCRIPTION/RESPONSIBILITIES: Description Kenvue is currently recruiting for: Quality Systems Specialist II This position reports to Manager Quality Systems and is based at Fort Washington PA Role reports to: Manager Quality Systems Location: Fort Washington PA Travel %: none Pay: 60K-96,600K What you will do The Quality Systems Specialist II is responsible for executing Document Management, Retention and Training processes in support of ongoing projects and daily GMP/GDP operations for Fort Washington Plant. Primary responsibilities include the development, coordination and maintenance of all site documentation and training activities. This position requires a thorough knowledge of documentation, training and retention requirements. S/He may act as a SME for one or more business processes, will provide support to internal stakeholders and establish strong relationships to ensure efficient process. Key Responsibilities Ensuring quality and compliance in GMP training, and identifying, reporting and seek corrections for deviations. Review/approve training documentation to ensure best practices of adult learning are applied while meeting customer needs. Collaborate with multiple functional areas (one-on-one or in a group setting), to develop standard, efficient processes and policies. Deliver training and/or support local Subject Matter Experts providing training, as needed. Including, but not limited to: GMP Orientation, Train-the-Trainer (T3) and routine GMP courses. Perform Learning Management System (LMS) transactions including user, item and curricula management, report generation and maintenance of content and completions. Perform document control activities to ensure GMP documents (controlled documents, logbooks) are managed as required by SOP and regulatory requirements. Support operational activities, including document issuance, reconciliation, reviewing and processing in the document management system. Provide support for the development of document templates, technical editing and formatting as needed. Serve as an administrator in the Electronic Records Management System (ERMS) which includes entering records, querying the system, filing and reporting metrics. Support and/or perform system validation/migration activities. Monitor functionality and communication between systems and related application. Support stakeholders by performing database searches, file retrieval, scanning & copying. Perform all task related to the document control room (Vault), receive, log and file, all documentation received in the Document Control Area. What we are looking for Required Qualifications Bachelor's Degree in a related field 2-4 years experience in a cGMP regulated environment Knowledge of FDQA, EMA and cGMP regulations Desired Qualifications Experience with pharmaceutical/OTC manufacturing is preferred Some experience in training is preferred What's in it for you Annual base salary for new hires in this position ranges from $60K-96,000K This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors. Competitive Total Rewards Package Paid Company Holidays, Paid Vacation, Volunteer Time & More Learning & Development Opportunities Employee Resource Groups This list could vary based on location/region Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Created: 2024-11-02