Quality Control Raw Materials & Stability Associate

Duties And Responsibilities

• Perform and/or coordinate testing for stability and raw materials as needed.
• Raw Materials - perform and/or facilitate testing at contract testing laboratories (CTL).
• Summarize data generated from CTL internally to support material release.
• Stability - perform stability testing on T-Cell final product as needed.
• Schedule/review of stability testing.
• Support authors of internal documents summarizing data generated for raw materials and stability samples as needed.
• Assist in document revision/authorship as needed. SOP’s, material specifications, protocols, and reports.
• Aid in data integrity checks.
• Aid in program improvements such as design/implementation of templates within LIMS.
• Aid in the qualification of critical ancillary and excipient raw materials used in the GMP manufacturing process.

Qualifications

• Bachelor’s or Associates degree in Biology, Biomedical Sciences, or a related field.
• 0-3 years of experience working in a GMP-regulated facility within the pharmaceutical or biotechnology industry.
• Novice working knowledge of cGMP regulations, USP, and EP testing requirements.
• Ability to analyze and interpret data, prepare trending reports, and contribute to test method development and SOP revisions.
• Attention to detail, organizational skills, and commitment to data integrity and compliance.

Desirable

• Experience with technical writing such as authoring/revising SOP’s, study protocols and reports, specification, Certificate of Analysis, etc.
• Familiarity with Quality documentation systems such as LIMS, DOT Compliance, PAS-X, and/or Veeva.
• Understanding of raw material and stability programs within the QC department.
• Experience coordinating with external testing laboratories.