Site Quality Manager
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Job Location:
Charlotte, VT - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Job Description:
As part of the Thermo Fisher Scientific team discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Are you ready to take on a pivotal role where you can make a significant impact on the world Thermo Fisher Scientific Inc. is seeking an ambitious Site Quality Manager to join the team in Charlotte NC supporting Filtration and Separation products sold globally.
Key Responsibilities:
Develop implement and maintain the sites Quality Management System (QMS) aligned with applicable regulatory standards (e.g. ISO9001 GMP ISO12485)
Lead a culture of continuous improvement promoting proactive identification and resolution of quality risks
Participate on the site leadership team in planning for the site incorporating quality initiatives into broader operational goals
Maintain compliance with all applicable regulatory and customer requirements and internal quality standards.
Responsible for internal and external audits including ISO customer and other external certifying bodies including implementation of Corrective and Preventive Actions (CAPA) for findings and deviations.
Lead and mentor the Quality team to provide the best possible service through effective communication scientific leadership and problem solving.
Navigate a sophisticated functional and technical matrix collaborate across functions troubleshoot problems interpret data and resolve next steps based on risk-based approach.
Track and report key performance indicators to assess quality system efficiency.
Ensure equipment qualifications process validations and calibration activities are properly completed and documented.
Qualifications:
Bachelors degree or equivalent experience in a scientific or technical field required.
5 years in Quality Assurance experience in the pharmaceutical bioprocessing food and beverage industries or other regulated industry.
Prior direct and matrix people leader experience.
Knowledge Skills Abilities:
Strong working knowledge of Good Manufacturing Practices (GMP) ISO9001 ISO9001 Good Documentation Practices (GDP) and CAPA systems.
Strategic problem solver with a practical approach to complex quality challenges.
Excellent communication and presentation skills including use of Microsoft Office tools.
Strong organizational and prioritization capabilities.
Proficiency in risk management tools such as FMEA Root Cause Analysis (RCA) and statistical process control (SPC).
Physical Requirements / Work Environment:
- Ability to work in a standard office environment including occasional visits to manufacturing ares that require cleanroom gowning.
Join us and contribute to our mission of making the world healthier cleaner and safer! We offer a collaborative environment where your outstanding skills will be valued and your career aspirations supported.
Required Experience:
Manager
Key Skills
- Computer Skills
- Lean
- Management Experience
- Process Improvement
- Warehouse Distribution Experience
- OSHA
- Process Management
- Training & Development
- LIHTC
- Leadership Experience
- Property Management
- Supervising Experience
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
