Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 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.

Location/Division Specific Information

The Frederick, MD location is a critical part of Thermo Fisher’s organization, providing support for up to 5 Business Groups and multiple divisions, from distribution, to Life Sciences and Corporate support. We are a leading provider of innovative products and services. Join our dynamic team in Frederick as a part of our Clinical Sequencing Division and shape the future of the world.

How will you make an impact:

A full-time role Monday-Friday 6am-2:30pm . This is an exciting opportunity to join Thermo Fisher Scientific where you will support the manufacturing documentation review department by facilitating timely release of batch records to ensure that customer needs are met while adhering to cGMP quality and compliance standards.

What will you do:

• Review manufacturing records with strong emphasis on Good Documentation Practices (GDP)

• Daily interaction and collaboration between production and quality team members to assist with timely resolution of quality issues and improve current documentation practices.

• Work in standard laboratory environment while adhering to room specific PPE requirements.

• Satisfactorily complete Thermo Fisher Scientific training requirements on time and operate within all ISO and FDA standards pertaining to Frederick site Manufacturing.

• Have excellent attention to detail of alpha and numerical text as well as symbols.

• Ability to peer review team members' work to catch errors and collaborate with the appropriate party to resolve.

• Must perform with high accuracy in performing all functions of this position as errors in work could cause customers to receive a non-conforming product.

• This position requires the individual to be ready to start work on-time daily and maintain strong attendance.

• Training will be provided through one-on-one instruction following process specific on-the-job-training until the operator is proficient to work individually.

• The incumbent normally receives general instruction on routine work and detailed instruction on new assignments.

Keys to Success:

Education

• High school diploma or equivalent required.

Experience

• Minimum of 0-2 years related experience

• Experience in a life science company preferred

• Batch records knowledge and experience preferred

Knowledge, Skills, Abilities

• Proven ability to follow policies and procedures, instructions, and to meet production schedules consistently and independently.

• Ability to work in a fast-paced environment with changing priorities.

• Computer skills such as proficiency with Microsoft Outlook, Teams, and E1 to support the operation in its daily functions.

• Strong quality-minded individual with prior experience working within a fast-paced cGMP manufacturing environment.

• Experience in an administrative setting with strong organizational skills and high attention to detail.

• Possess a positive and professional demeanor.

• Places a strong importance on teamwork and peer collaboration.

• Possess strong communication abilities, verbally and written.

• Biology or chemistry background (preferred but not required)

Physical Requirements / Work Environment

Ability to lift up to 40 pounds.

Work in a GMP manufacturing environment. Must follow PPE requirements specified within the Manufacturing area including: Wear company provided hairnet, beard net (if applicable), lab coat, safety glasses. Must wear closed shoes (no open heel/top/toe areas), maintain no exposed skin other than neck, face and hands.

As a documentation review team member you'll be working mostly with computers and documents.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.

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.

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.