Manufacturing Quality Assurance Engineer

Agilent TechnologiesFrederick, CO
1d

About The Position

Provides quality guidance and expertise to ensure QC data, testing, and processes meet CGMP standards and regulatory requirements. 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. 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).

Requirements

  • 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 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).

Nice To Haves

  • Experience with QC testing as it relates to Oligonucleotide testing and production is preferred.

Responsibilities

  • Provides quality guidance and expertise to ensure QC data, testing, and processes meet CGMP standards and regulatory requirements.
  • 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.
  • Responsible for QC data approval.

Benefits

  • eligibility for bonus
  • stock
  • benefits
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