Document Review Team Lead

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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.

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.

Location: Frederick, MD - Executive Way

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:

  • Minimum Associates Degree with 3 years experience
  • Bachelor's degree or equivalent experience require with a 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



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.

More Information on Thermo Fisher Scientific
Thermo Fisher Scientific operates in the Biotech industry. The company is located in Waltham, MA, Carlsbad, CA, Pittsburgh, PA and Lenexa, KS. It has 100000 total employees. It offers perks and benefits such as Volunteer in local community, Eat lunch together, Intracompany committees, OKR operational model, Team based strategic planning and Dedicated diversity and inclusion staff. To see all 208 open jobs at Thermo Fisher Scientific, click here.
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