- Provide quality assurance and quality control proficiency testing concepts, operating principles, regulations, and methodologies to evaluate and resolve complex laboratory issues.
- Maintain working knowledge of inspection, testing, and measurement techniques, including statistical analysis and sampling techniques, to study quality problems in a laboratory environment.
- Coordinate in-house and external QC testing activities and material disposition (authorize batch releases, holds and discards).
- Analyze and report all QC tests (Biological assays, HPLC, SDS-PAGE gels, Endotoxin, ELISA, etc.).
- Interface with clients to handle all product inquires and complaints - through phone calls, emails, website, etc.
- Perform and direct root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
- Review scientific publications to identify product usage and update our website accordingly.
- Complete change notifications, advising not only office worldwide, but also distributors.
- Coordinate updates for the company website with relevant product updates and responses.
- Coordinate support inquiries and provide updates to offices worldwide.
- Generate all certificates and SDS for products.
- Support and maintain the Quality System.
- Provide product support and updates to offices worldwide.
- Follow ISO 9001 and GMP guidelines, where applicable.
- Demonstrate and drive the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The Four I's).
- Bachelor's degree is required.
- Minimum of 1-2 years' work experience in a similar or relevant field.
- Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.
- Strong ability to work independently and as part of a team.
- Capability of working without direct supervision.
- Excellent interpersonal skills.
- Strong attention to detail with the ability to detect errors and inconsistencies in various types of documents.
- Ability to create, revise and interpret complex technical documents.
- Strong computer skills: application proficiency and database management with Word, Excel, Adobe Acrobat, and other programs as required.
- Flexibility and willingness to work in a team-based environment.
- Ability to prioritize among multiple projects while maintaining deadlines.
- Ability to analyze and define problems, collect data, establish facts, and draw valid conclusions.
- Knowledge of ISO 9001 standard and certification requirements preferred, or training will be provided as needed.
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Quality Specialist III - Cranbury, United States - Thermo Fisher Scientific
Description
Job Description
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
Our Recombinant Proteins (REP) Business Unit in Cranbury, NJ is part of our Biosciences Division. REP unites deep scientific expertise with a collaborative culture to build a product portfolio that includes cytokines, growth factors, antibodies and ELISA kits used to support the research of our academic, government, biotech, and pharmaceutical customers.
Discover Impactful Work:
The Quality Assurance and Support Analyst performs various duties relating to maintaining the quality and consistency of products sold to customers as well as preparing and maintaining necessary documentation. This employee is responsible for initiating tests, reporting results, updating records, responding to inquiries, and other tasks pertaining to the company's products. The employee performs all duties in accordance with leading standards, practices, and guidelines. The role will report to the Quality Assurance Manager- Recombinant Proteins Business.
A Day in the Life:
Keys to Success: Education
Experience
Knowledge Skills and Abilities
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
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.