Mgr II - Quality Req : 190002YB_en Location: Jayuya, PR US Job Category: Quality Date Posted: 3/21/2019 5:41:52 PM Baxter International Description Quality Operations/Disposition Process: Ensure Quality presence in the production processes to strengthen compliance on SOP's and cGMP's on all manufacturing and packaging process activities. Responsible for the supervision and development of Quality Supervisors and process auditors (Quality Technicians) ensuring that appropriate actions are taken during operations to ensure compliance with internal procedures, company policies, regulatory requirements and current standards. Ensure product inspection plans are developed and carried out using appropriate statistical sampling plans / methodology. Manages the product disposition process to assure that Finished Goods meet all quality specifications. Manages quality programs and systems, such as: Retain Samples. Maintains appropriate QA staffing to support functions and responsibilities. Keeps the Quality Director informed of any know potential and / or existing issue(s) related to his/her areas of responsibility. Implement Lean Culture Tools throughout the organization. Maintain a 6's environment in the areas. GENERAL DUTIES AND RESPONSIBILITIES One manager must have an active Puerto Rico Pharmacist License. Applies total quality management tools and approaches to analytical and reporting processes within each department. Assure that his/her staff, supervisors, and employees follow all federal, state, and company requirements. Plays active role on quality management team within organization. Work with minimum or no supervision. Drives the team to achieve the proposed goal in compliance to all internal and external regulations and standards. Performs weekly, monthly and annually reports as required by Plant Managers, Corporate Managers or any audit (Corporate, FDA, ISO 9000). Develops, assigns and implements systems, procedures and policies to assure compliance with ISO Standards, cGMP's and FDA regulations. Occasionally carries out the functions of the Quality Director (in absence of the incumbent; vacations, sick leave, business trip) as requested by Quality Director. Performs department budget in accordance to all area needs. Assures that all resources are maximized in a safety and quality manner. Supports directly the Plant paperless strategy. Responsible to supervise and support all area associates, assuring a teamwork environment. Serves as a team leader to establish working teams. Trains and integrates new associates. Coordinate duties, projects, and responsibilities. Should be able to communicate at all Plant and Divisional levels. Provide technical support to other Quality areas as assigned. Fill out all department documentation in compliance with all standards. Works or handles multiple tasks and projects simultaneously. Willing to travel. SUPERVISORY RESPONSIBILITIES Manages subordinates in Quality System Department. Responsible for the overall direction, coordination, and evaluation of these personnel. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Qualifications QUALIFICATIONS EDUCATION and/or EXPERIENCE Bachelor's degree (BS) in Sciences or Engineer with eight to ten years related experience; or Bachelor Degree in Pharmaceutical Science with 5-7 years' experience or Phar.D. with 2-4 years' experience. Manager must have an active Puerto Rico Pharmacist License. Excellent communication skills. Excellent knowledge of Federal and Local regulations (such as: FDA, ISO / EN). Computer knowledge. Experience in managing Standard Operating Procedures (SOP's) and documentation audit programs. Excellent interpersonal skills, Communication skills (verbally, written, visual), fully bilingual (English and Spanish). Knowledge of Microsoft Office (Word, Excel, Power Point, etc.). Knowledge in Six Sigma, Lean, and statistic are desirable. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTAbaxter.com and let us know the nature of your request along with your contact information. SDL2017
