Data Reviewer 1
Company: Kelly Services
Location: West Chester
Posted on: April 10, 2021
Data Reviewer 1West Chester, PAFull-Time, Dayshift--JOB SUMMARY:
The Data Reviewer 1 is responsible for review and approval of data
generated in the laboratory in a timely and effective manner
according to methods, instructions, procedures, good laboratory
documentation practices (GDP), good manufacturing practices (GMP)
and standard operating procedures (SOPs). This job also requires
the ability to demonstrate a high commitment to interpersonal
relations.----Follow Training SOP for training and training
records. Comply with company Code of Integrity and Professional
Conduct and conduct all testing to the highest level of cGMP
compliance.--SERVICE RESPONSIBILITIES TO CUSTOMERS--
- Perform data review following staff performance of customer
test requests in a timely and effective manner. Customer test
requests include wet chemistry, instrumentation and/or
microbiological data reviews.
- Perform reviews for reagent and standard preparations and their
assays or suitability testing and/or media preparation and
associated media checks. Perform equipment performance logs review,
auxiliary logbook reviews, stability study pull reviews, audit
trail reviews and metrology reviews.
- Perform special project data review following staff performance
of customer test requests in a timely and effective manner.
Customer test requests include wet chemistry, instrumentation
and/or microbiological data reviews.
- Perform Out of Specification (OOS) and Method Validation
Failure (MVF) wet chemistry and/or microbiology investigations
following staff performance of customer test requests in a timely
and effective manner.
- Ensure that all testing submitted by customers is completed
within established parameters governing Company quality and
regulatory compliance specifications.--SERVICE RESPONSIBILITIES TO
- Ensure that all reasonable requests from Department Management
pertaining to review of laboratory data supporting a given test or
group of tests are met in a timely and effective manner.
- Play a role in Departmental or company-wide projects designed
to improve the internal efficiency and overall quality of work
performed at the laboratory.
- Play a role in creating and maintaining an atmosphere of
teamwork throughout the laboratory.--TECHNICAL RESPONSIBILITIES--
- Assures that reviewed QC records are compliant to methods,
specifications, and company's applicable Standard Operating
- The review is done according to Data Review SOP
- Identifies area for improvement of company SOPs, analytical
methods, and forms.--
- Follows deadlines specified on a lab sheet or as scheduled by
- Assures records of Method Validation/Method Transfer/Method
Verification and reports are as per protocol and method provided by
clients or written by the company.
- Assures that OOS and deviations are closed before forwarding
the records to QA for release of C of A.
- Ensures test results are reported appropriately on either a C
of A or a R of A depending on the validation/transfer status of the
- Assures review of data in a timely manner and approval of
records prior due date.
- Assures method development records are reviewed as per company
- Issues an audit form noting deficiencies to method and
procedures, returns the form to analyst for correction according to
Data Review SOP; Ensures that all valid deficiencies are corrected;
escalates all concerns to management.
- Informs analyst or his/her supervisor to initiate out
-of-specification and/or issue OOS form in case of OOS, which was
not noted by analyst.
- Audits all record books (logbooks) associated with testing
reviewed / approved.
- Ensures that documentation review is complete in every respect
and reviews that all results are entered into the electronic
laboratory information system LIMS.
- Attends training sessions and ensures that training binder is
current. Has a training record for every SOP version executed, if
applicable; If absent during training sessions, ensures training is
performed and documented.
- Reviews and approves solution preparations and labeling.
- Requests training if work assigned requires knowledge of SOP
with no record of training or reads and asks questions about SOPs
- Audits calibration related documents and other QC
- Inputs data for trending departmental KPIs.
- Identifies, participates in, and sometimes leads operational
- Minor participation in regulatory, and client audits
- Adherence to relevant SOPs governing documentation and
- Adherence to applicable personnel policies regarding time
clock, telephones, sick days, vacation days, etc.
- Participation in general staff training sessions as these are
- Education: B.S. in Biochemistry, Chemistry, Biology or
- Experience: 0- 2 years of experience working in a
pharmaceutical regulated Laboratory environment or Pharmaceutical
- Ability to critically evaluate and review almost all test
- Comfortable with electronic systems (e.g., LIMS) and other lab
equipment to be able to perform audit trail of testing
- Experience and understanding of HPLC data.
- Able / willing to learn new skills (review of new tests,
instrumentation, and procedures) as required and follow directions
from management including priorities.
- Technically competent
- Ability to learn quickly in a challenging environment.
- Excellent language, writing and communication skills
- Thorough knowledge of scientific principles pertaining to
analytical records reviewed.
- Ability to interpret, analyze data and draw logical conclusions
- Must be well organized and able to work effectively and
- Ability to work well with others, independently and fostering
teamwork throughout the laboratory.
- Proven time management skills and a strong attention to
- Responsible to deadlines
- Proficient in using various types of computer software (Word,
Excel. PowerPoint & Outlook, LIMS, and equipment software).
- Proven ability to manage and coordinate multiple projects in a
fast-paced, highly professional environment.
- Appropriate attitude, constant vigilance, attention to detail
and following Training SOP for training and training records.
- As per SOP, all employees must maintain appropriate attitude,
constant vigilance, and attention to detail. Understanding of the
lab quality control / quality assurance processes, GMP and GDP as
it relates to pharmaceutical testing.Why Kelly--?Kelly Science &
Clinical is your connection to premier scientific and clinical
companies looking to hire talented people just like you. Every day,
we match science professionals with dream jobs that fit their
skills and interests-it's the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Kelly Services, Wilmington , Data Reviewer 1, Other , West Chester, Delaware
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