Manager I Quality

Description Essential Duties and Responsibilities: Responsible for the control of the revision levels, effective dates, release, and correct implementation of all documentation in BPLM, such as the Standard Operating Procedures, Manuals, Analytical Test Methods, Packaging Modules, Master Batch Records, Forms, Bill of Materials (etc.), assuring consistency and compliance according to cGMPs and established documentation control requirements. Responsible for tracking and circulation of the above-mentioned documents to their designed Book Locations throughout Baxter Guayama. Ensure applicable revision update into ISOTrain of the Standard Operating Procedures, Manuals, Analytical Test Methods, Packaging Modules and/or Master Batch Records. Ensure applicable revision and effective date verification into LIMS Software of the Standard Operating Procedures and Manuals. Maintenance of the Quality File Room. Supervise all activities related to issuance of Master Batch Records and/or Packaging Modules, and any additional tasks as deemed necessary. Lead and support process and procedure simplification initiatives Constantly suggest and act on documentation /quality records related opportunities for improvements. Qualifications Qualifications: (List knowledge, skills, and/or abilities required) Results driven in a fast pace work environment Knowledge /computer wise experience of Microsoft applications. Able to make judgments based on past experiences and established practices and procedures. Document processing or knowledge and usage of office equipment. Able to demonstrate responsiveness to customer needs, within job scope. Effective oral and written communication skills (English/Spanish) and personal conflict resolution skills. Ability to organize workload and prioritize tasks. Ability to communicate with all levels within the organization. Ability to work efficiently under tight deadlines. Lean six sigma principles knowledge Education: Essential: BS in Science related field or Industrial Engineering Desirable: Advanced