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QC Data Reviewer
Job Title: QC Data Reviewer
Location: Philadelphia, Pa
Start Date: Immediate
- Review and verify accuracy and completeness of documents such as assay execution run records, reagent preparations, data and data tables, instrument logs, etc., according to regulatory requirements and good documentation practices; working with lab scientists to resolve documentation deficiencies
- Establish quality control processes such as writing up procedures and designing checklists for document review to support preclinical and clinical sample analysis
- Create templates and format documents using the Microsoft Office suite (Word, Excel, etc.)
- Author controlled, technical documents such as SOPs, technical protocols and reports
- Perform document control quality reviews and edits of the documents authored by other group members, ensuring correct data, clarity, grammar, style, template adherence, etc., according to accepted standards
- Archive documents
- Facilitate training of group members on regulatory requirements and good documentation practices
Education and Experience Requirements
- BS/BA or higher in relevant scientific discipline (health care, life science, biology, biochemistry, etc.)
- Generally has 1-3 years of document quality control or quality assurance experience in a CRO or biopharmaceutical environment;
- Experience in QC or QA review of lab generated records and data within the pharmaceutical/regulated industry;
- Technical writing experience with the ability to provide work examples of such experience;
- Good understanding of biological assays such as ligand-binding immunoassays, e.g. ELISA, ELISPOT, cell-based assays, qPCR assays, etc.; Hands-on experience running these assays preferred, but not required;
- Good understanding of GLP/GMP/GCP, Good Documentation Practices and regulatory guidance;
- Excellent written and verbal communication skills.
Key Skills, Abilities, and Competencies
- Past experience in QC review of biological assays compliant with regulatory requirements;
- Technical writing skills and proficiency of Microsoft Office programs;
- Ability to work independently and manage work to defined schedules;
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