Document Control Administrator

at  Thermo Fisher Scientific

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.

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.

• 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: