Quality Assurance Manufacturing Engineer, Advanced

Job description

Job Description: Primarily supports the Quality Control group by resolving QC lab investigations and data review. Provides experienced quality-related support in collaborative environment with Quality Control, Analytical Services, Quality Assurance, Manufacturing, Technical Services, Production and Supply Chain. - Provides quality guidance and expertise to ensure QC data, testing, and processes meet CGMP standards and regulatory requirements. - Responsible for QC data approval. - Experience with HPLC, Spectrophotometry, UV , Sequencing, Gas Chromatography, FTIR, Moisture Analysis, and general experience in Raw Material, Intermediate, and Finished Goods testing. - Experienced in Quality Control data results, interpretation and lab investigation resolution. - Experience with good understanding in lab information management systems (LIMS). Qualifications: Bachelor's or Master's Degree in the sciences (biology, chemistry, biochemistry) or equivalent industry experience in quality assurance. 4+ years relevant experience for entry to this level. Must have experience in CGMP, especially related to Quality Control (QC). Experience with QC testing as it relates to Oligonucleotide testing an...