QC Specialist

Job Description:  The principle responsibilities of this employee are to conduct routine Quality Control (QC) reviews of GxP-regulated data generated by the Bioanalytical Operations group. The QC Specialist will assist in identifying deviations, CAPAs, lab investigations, OOS and OOT that are associated with Bioanalytical Operations data.  The employee will perform technical QC review and work closely with Scientists and QA to ensure that timelines for studies are met.  The employee will assist in collecting data for metrics that will be used to monitor the QC processes.  After a short training period, this employee will work independently with minimal supervision.

Position Requirements:  A degree in biology, chemistry, or other scientific or related field with 2+ years’ experience in pharmaceutical / biotechnology / CRO preclinical / clinical quality operations.  Experience with immunoassays and/or cell-based assays.  Experience reviewing bioanalytical data to GxP standards.  Current knowledge of FDA GxP regulations and industry standards as they apply to the life sciences and pharmaceutical industries. Ability to work in a fast-paced team environment where multiple projects are in process and must be completed in a timely manner.  Excellent oral and written communication skills are essential. Proficient use of computer and Microsoft software programs.

Status: Temporary to Full-time


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