As part of the Thermo Fisher Scientific team, you'll 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 world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position will be site based in Cranbury, NJ and will support the Life Sciences Solutions Group (LSG). Reporting to the Quality Assurance Systems Manager for the Recombinant Proteins business unit.
Discover Im pactful Work:
We are seeking a highly motivated and meticulous Quality Systems Specialist to join our team. The Quality Systems Specialist will play a meaningful role in the implementation, maintenance and improvement of the company's quality assurance program, the Quality Management System (QMS) and ensuring that other departments operate in accordance with the highest quality standards and align with all applicable requirements.
A Day in the Life:
Maintain the company's Quality System based on ISO 9001:2015 standard.
Facilitate the identification, investigation and effective closure of deviations, non-conformances and corrective and preventive actions (CAPAs).
Review quality-related documentation such as manufacturing records, worksheets, training forms, etc. for legibility, accuracy and completeness.
Ensure the accuracy, accessibility and version control of key company documents, including SOPs, work instructions, test methods and checklists.
Perform daily tasks critical to the smooth operation of the PeproGMP product line. Tasks include but not limited to: material and product quarantine and release, batch record and label issuance, etc.
Coordinate in-house and external QC testing activities (sample submissions, results analysis, and reporting) and material disposition. Tests include Biological Assays, HPLC, SDS-PAGE gels, Endotoxin, ELISA, etc.
Analyze quality data such as environmental monitoring, complaints, etc. to identify quality issues and recommend corrective and preventive actions (CAPA) for continuous improvement.
Collaborate with other departments to develop and maintain a robust QMS.
Support/perform internal audits, including Quality Management System audits.
Perform external audits where applicable (may require up to 25% travel).
Follow all ISO 9001 and GMP guidelines.
Demonstrate and drive the Thermo Fisher values - Integrity, Intensity, Involvement, and Innovation (The Four I's).
Keys to Success:
Education
Bachelor's degree or technical education equivalent to a 4-year college degree preferred.
High school diploma or equivalent required.
Experience
Minimum of 2- 3 years' work experience in a similar or relevant role.
Prior experience working in a controlled GMP environment is ideal.
Good understanding of ISO 9001 standard preferable.
Knowledge, Skills, Abilities
Strong communication skills (written and verbal).
Strong computer skills, including ability to collect, organize, and interpret data electronically.
Ability to work independently, and without direct supervision.
Ability to create, revise and interpret complex technical documents.
Consistently exhibits a high level of attention to detail.
Strong organizational skills, including the ability to handle multiple projects, prioritize and thrive in a fast-paced environment.
Consistently exhibits a high level of attention to detail.
Ability to define problems, collect data, investigate, and tackle problems efficiently.
Understanding of GMP production and inherent procedures.
Proven track record of conducting presentations and trainings.
Knowledge of ISO 9001 standard and certification requirements, or training will be provided as needed.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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