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Data Reviewer

Company: Thermo Fisher Scientific Inc.
Location: High Point
Posted on: June 9, 2021

Job Description:

Job Description

Job Title: Data Reviewer

Requisition ID: 157404BR

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 over $28 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:

This role will be based at our High Point, NC facility.

How will you make an impact?

The Data Reviewer is responsible for data review of any of the following: Raw Materials, InProcess, Finished Product, Stability, Technical Service samples or projects within the QC/PDS laboratories (Chemistry and Microbiology), in a manner consistent with established standards. In addition, the Data Reviewer position may have a significant portion of their function dedicated to Laboratory Data Integrity Compliance activities as mandated by Corporate Standards.

What will you do?

80 - 90% Documentation/Data Review

* Demonstrate ability to understand the operation of analytical instrumentation such as HPLC, GC, FTIR, and UV. * Perform review of raw data from analyst laboratory notebooks/electronic notebooks, solution preparations notebook, and logbooks as needed. * Assist in the completion of certificates of analysis of lots tested.

Up to 10% Laboratory Data Integrity Compliance

* Ensure data integrity practices and procedures are implemented in QC/PDS and adhered to for quality compliance and to meet industry standards. * Ensure all new and existing equipment are assessed appropriately and validated for their intended use and existence. * Provide reviews of audit trails.

Up to 10% Training and Development

* Participate in ongoing training for the development of skills and responsibility with an emphasis on technology. * Ability to actively participate on various and/or lead projects or teams and propose solutions to problems encountered by such teams.

How will you get here?

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry or related field with at least 5 years of related experience in an analytical laboratory setting, preferably in a Quality Control or Analytical Development Laboratory in a GMP facility.

Knowledge, Skills, Abilities:

Compliance: Actively contribute to the overall goals of the company. Follow all company policies, standard operating procedures, cGMPs, work instructions, methods and analyst's guidelines.

Productivity: Multi tasks and schedules time to meet required workload. Actively seek additional assignments. As required by the group's workload, is available for off-shift or weekend assignments, or for emergency/problem situations.

Written Communication: Record and/or review all data and documents all activities in accordance with applicable guidelines, SOPs and Company policies. Documents all aspects of assignments in the laboratory notebook. Writes laboratory SOP's and Work Instructions (WI), summaries and reports.

Verbal Communication: Maintain continuous communication with analysts to facilitate their work. Notify the supervisor or delegate immediately of any possible situation about productivity or activities that require decision making beyond his/her scope. Maintain and support a positive workplace attitude towards individuals and company. Communicate with personnel from other departments during meeting and specific tasks assigned by management. Represent the supervisor in delegated meetings.

Initiative and leadership: Train peers to perform specific data review. Independently pursue training and/or learning opportunities to enhance personal skills and share skills with other team members. Assist in the training and coaching, leading other reviewers into excellent compliance status. Coordinate tasks of other reviewers to assure product release goals are reached.

Safety & security: Maintain an organized workspace. Demonstrate a positive attitude towards safety and housekeeping audits. Use proper personal protective equipment when required. No lost time work accidents caused by negligence or unsafe acts. Identify and resolve unsafe situations. Immediately report any accident or near miss to Supervisor or delegate. Secure area of responsibility when required. Protect confidential and restricted information.

General: Perform other related, reasonable business duties.

Qualifications to perform this job successfully: an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.

Keywords: Thermo Fisher Scientific Inc., High Point , Data Reviewer, Other , High Point, North Carolina

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