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
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
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
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
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
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