Quality Control Data Reviewer
Company: Rentschler Biopharma Inc.
Posted on: May 16, 2022
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
- 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
- Solve problems and make decisions with assistance.
- Assist with authoring SOP's, investigations, deviations and
- 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
- Work cooperatively within the QC department and with other
departments to achieve project goals.
- Support all data integrity initiatives and strive for right
- 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
- Work is to be performed on site
Keywords: Rentschler Biopharma Inc., Worcester , Quality Control Data Reviewer, Other , Milford, Massachusetts
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