Document Review Team Lead (Washington DC)

| Washington DC
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Job Description

Job Description:

When you are part of the team at Thermo Fisher Scientific, you will do important work and you will be valued and recognized for your performance. With hardworking managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.

Job Summary:
To support the Formulations, Fill, and Finish Value Streams within Manufacturing Operations by overseeing daily work performed in the Manufacturing Document Review Room.

Job Responsibilities:
  • Support and maintain production standards.
  • Ensure employees are following company policies and is responsible for issuing warnings if/when needed.
  • Manage shift-to-shift communications to ensure seamless transition of work between shifts.
  • Promote a safe and positive team environment to achieve daily production goals.
  • Direct the daily workload to ensure schedule completion while managing utilization and efficiency
  • Trend production metrics to identify areas of improvement.
  • Monitor and ensure compliance with ISO/GMP/FDA/class 7 requirements.
  • Maintain the Quality System by following SOP's and work instructions.
  • Assist/Lead departmental projects to promote Practical Process Improvement (PPI) and achieve cost saving goals.
  • Complete manufacturing review of production documents and close work orders as needed without delay or backlog
  • Open and manage problem reports/CAPA as needed.
  • Work overtime as needed including both Saturday's and Sunday's

Nature and Scope:
The Manufacturing Operations Document Review Team Leader, is responsible for overseeing operations of one or more work centers with general responsibility for reviewing and correcting all production records used by Manufacturing Operations. Safety, Quality, and Compliance will be core to every activity. You will maintain a skilled manufacturing team and will be responsible for the daily production of Team members. The Lead will also effectively communicate during daily shift changeover to promote both inter and intra shift cohesion. This position requires the individual to be ready to start work on-time daily and maintain strong attendance performance.

Qualifications:
  • Bachelor's degree or equivalent experience required
  • Minimum of 1-3 years related experience, preferably in a regulated industry
  • Proven ability to consistently and independently follow policies and procedures, instructions, and to meet project timelines
  • Ability to work in a fast-paced environment with changing priorities and many distractions
  • Strong written and verbal communication skills
  • Ability to teach others and explain complex issues in simple terms that is non-confrontational
  • Proficiency with Microsoft Office Suite to support daily operations.
  • Demonstrated ability to apply problem solving methodology to understand root cause and implement solutions.
  • Lean manufacturing experience
  • Excellent time-management skills
More Information on Thermo Fisher Scientific
Thermo Fisher Scientific operates in the Biotech industry. The company is located in Waltham, MA. Thermo Fisher Scientific was founded in 2022. It has 61393 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 497 open jobs at Thermo Fisher Scientific, click here.
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