Quality Assurance Operations Lead- Onsite

Sartorius

  • Yauco, PR
  • Permanente
  • Tiempo completo
  • Hace 5 días
This role will be responsible of support the quality technical aspects and activities for Cell Culture Media Operations. The holder of this position will support the implementation of quality initiatives and continuous improvement to support the company Quality Management System. Plans, schedules, executes, and communicates all items regarding Quality issues, events, complaints, validations, and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards ad applicable regulations. Environmental Health and Safety (EHS) Regulations, Occupational Health and Safety Administration System (OSHA) Regulations. GMP, ISO, GDP Will support several quality functions such as validation activities, process characterization, cleaning validation, QC method transfers and other manufacturing/operations activities. Responsible for projects execution and implementation and will become a subject matter expert in the processes assigned. In addition, will have direct responsibility of tasks and activities necessary to keep quality processes efficiently and meeting established key performance indicator requirements.What you will accomplish together with us - Main Responsibilities & Tasks:Experience in Methods related to Cell Culture.Experience in Equipment and Process Validation.Experience with Supplier Qualification and/or raw material qualificationExperience with Change Control processAbility to review validation documentation.Development, execution and approval of all plant, division and corporate protocols including coordination with the Manufacturing and Engineering Teams.Skills in overseeing/assessing existing processes and workflows.Improve quality processes by designing, implementing and testing new procedures.Track metrics KPIs and other relevant data to discover areas of improvement and monitor upgrades.Use continuous improvement methodologies when applicable.Create / Revise process documentation and operating instructions (SOPs / WIs).Perform, review and approve Non-conformance / CAPAs / Complaints Investigations, if required.Ensure timely and efficient completion of assigned projects.Ensure tasks and activities performed comply with applicable standards and proceduresAssist in internal/external/corporate audits.To constantly strive to instill a sense of professionalism and pride in the organization personnel by ongoing daily communication & leadership by example.Keep effective communication with quality, manufacturing and engineering teams.Utilization of methodologies to test and find the most appropriate quality and risk strategiesAssessing due compliance with applicable safety and quality standards.Hands on attitude, Team spirit.Support manufacturing engineer in process validations, process control, process training programs, process improvement, risk management, and software validations and control.Review and/or develop protocols for validation, evaluate data, and write reports – including generation statistical analysis of quality data.Experience with Stability Studies and Aseptic processes is a plusWhat will convince us - Qualification & Skills:Bachelor's degree in Chemistry, Biology, Engineering or other Technical Area. 10+ years within the regulated industry.Fully bilingual (Spanish and English, written and spoken)Customer service oriented: Must have good interpersonal and communication skills to provide adequate service to internal and external customers. Must maintain a high level of confidentiality, standard of ethics and integrity. Analytical and problem solving: must be able to identify solutions to problems within scope of responsibility and implement corrective action.Able to effectively work, communicate (written and oral) and collaborate with peers and other business areas.Change Management: must be able to develop workable implementation plans and communicate changes effectively.Effective Prioritization, Planning and Time Management: Must be able to organize and plan workload on several projects concurrently to meet deadlines.Cost consciousness: ability to work within approved budget while developing and implementing cost saving measures.What we offerPaid vacation and sick leave
14 paid holidays annually
Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees.
We offer an open-office concept, a spacious outdoor area, conference areas and a development center.
Medical, Dental and Vision insurance along with Company Retirement Plan
On-site cafeteria and coffee shop
On-site occupational health offices including Laboratory Services & DoctorsDriving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.Please view equal employment opportunity posters provided by OFCCP hereE-Verify Participation InfoE-Verify Workers Rights

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