Data Reviewer 1

Company: Kelly Services
Location: West Chester
Posted on: April 10, 2021

Job Description:

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 INTERNAL CUSTOMERS--
  • 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 Procedures.
      • 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 their supervisor.
      • 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 method.
      • Assures review of data in a timely manner and approval of records prior due date.
      • Assures method development records are reviewed as per company SOPs.
      • 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 in training.
      • Audits calibration related documents and other QC documents.
      • Inputs data for trending departmental KPIs.
      • Identifies, participates in, and sometimes leads operational improvement initiatives.
      • Minor participation in regulatory, and client audits needed.----ADMINISTRATIVE RESPONSIBILITIES--
        • Adherence to relevant SOPs governing documentation and reporting.
        • Adherence to applicable personnel policies regarding time clock, telephones, sick days, vacation days, etc.
        • Participation in general staff training sessions as these are scheduled.----EDUCATION REQUIREMENTS:--
          • Education: B.S. in Biochemistry, Chemistry, Biology or equivalent.--
          • Experience: 0- 2 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical company.----
            • ----
              • Ability to critically evaluate and review almost all test records generated.
              • Comfortable with electronic systems (e.g., LIMS) and other lab equipment to be able to perform audit trail of testing records.
              • 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 required.
              • Thorough knowledge of scientific principles pertaining to analytical records reviewed.
              • Ability to interpret, analyze data and draw logical conclusions required.
              • Must be well organized and able to work effectively and efficiently.
              • Ability to work well with others, independently and fostering teamwork throughout the laboratory.
              • Proven time management skills and a strong attention to detail
              • 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 Law.]]

Keywords: Kelly Services, Wilmington , Data Reviewer 1, Other , West Chester, Delaware