Quality Specialist I
Thermo Fisher Scientific

Job Description

Quality Assurance Specialist I Job Description

About Thermo Fisher Scientific

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery! With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. For more information, please visit www.thermofisher.com.

Position Summary:

Assist and support the organization in meeting Quality objectives and assure compliance with industry standards. Determine, organize and apply necessary resources to meet identified Quality Requirements. Ensure Corporate, Regulatory, Quality requirements are met. Ensure that customer expectations are met or exceeded.

Responsibilities:

• Generate Finished Product Labels
• Maintain imaging program and process for Quality Documents
• Log TrackWise records when needed/applicable
• Participate & Maintain Investigative Processes (PNs, Deviations, CAPA)
• Review Lot records prior to release
• Release Manufacturing Lots
• Participate in self inspection activities as assigned
• Generate COA Templates
• Participate in other QMS efforts such as CAPA, Non-conformances, document control, training, supplier quality, etc.
• Participate in PPI (continuous improvement) events

Quality Responsibilities:

• Observes all departmental and Quality System procedures and work instructions.
• Supports Thermo Fisher Scientific's commitment for continuous improvement by documenting process improvement opportunities thorough the Quality System.

Preferred Experience:

• 0-1 years experience working in cGMP environment
• Direct experience of working with ISO 13485, FDA 21CFR Part 820 and FDA 21 CFR Part 11
• Experience with Oracle, MasterControl, and TrackWise

Minimum Requirements/Qualifications:

• High School Diploma or equivalent minimally required
• Ability to work independently with little direct supervision
• Proficient with Microsoft tools; Word, Excel, Power Point, Teams
• Organization Skills
• Attention to detail
• Problem solving skills
• Strong teamwork and collaboration skills
• Organized and clear technical writing: ability to communicate technical and analytical language in written prose executive summaries and conclusions
• Demonstrate knowledge of Quality management System tools, continuous improvement methodologies, in-depth understanding of products and processes
• Excellent interpersonal, organization, and influencing skill
• Excellent communication, written and presentation skills
• Must be comfortable working primarily at a desk, in an office setting
• This position requires following cGMP (Current Good Manufacturing Practices) and working in a fast-paced team environment

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 1-855-471-2255*. 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.

This job has expired.