Quality Assurance Operations Lead- Onsite
Quality Assurance Operations Lead- Onsite
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 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 qualification
Experience with Change Control process
Ability 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 procedures
Assist 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 strategies
Assessing 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 plus
What will convince us - Qualification & Skills:
Bachelors 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 offer
- Paid vacation and sick leave
- 14 paid holidays annually
- Impressive campus: Located on 219000 square meters our campus is home for more than 1000 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 & Doctors
Driving 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 OFCCPhere
About Sartorius
Sartorius is part of the solution in the fight against cancer dementia and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
Employment Type
Full-Time
Key Skills
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved