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Quality Control Data Reviewer

Company: Rentschler Biopharma Inc.
Location: Milford
Posted on: May 16, 2022

Job Description:

Job DescriptionAs part of the Milford site's Quality Control team, the data reviewer is responsible for the cGMP analytical data review and paperwork generated during laboratory analysis in the quality control laboratory. Data review may consist of all/some of the following:

  • In process and release analysis
    • Raw material analysis
    • Microbiology analysis Duties and Responsibilities
      • Perform analytical data review of cGMP data in a timely manner in support of the quality control group to ensure accuracy and quality of data.
        • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
        • Exercise judgment within generally defined procedures and practices.
        • Solve problems and make decisions with assistance.
        • Assist with authoring SOP's, investigations, deviations and change controls.
        • Assists with OOS and OOT investigations, deviations, change controls and CAPA's
          • Assists with investigations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
          • Work cooperatively within the QC department and with other departments to achieve project goals.
          • Support all data integrity initiatives and strive for right first time.
          • Create/revise SOPs, Protocols and Reports.
          • Assists with metrics for trending and reporting, stability and QC analytical data.
            • Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask.
            • Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems.
            • Exceptional communication and interpersonal skills.
            • Assists in training of new hires and retraining of QC laboratory staff, as needed.
            • Performs other duties as assigned. Qualifications
              • B.S. in Chemistry, Biology, Microbiology, Chemical Engineering, or related biological sciences.
              • 2+ years in a cGMP analytical laboratory environment, non-lab or equivalent industry experience.
              • 2+ years of experience in technical writing and QC GMP data review Working Conditions Rentschler-Biopharma, Inc. values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
                • Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
                • Able to use and learn standard office equipment and technology with proficiency
                  • Work is to be performed on site

Keywords: Rentschler Biopharma Inc., Worcester , Quality Control Data Reviewer, Other , Milford, Massachusetts

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