Quality Control Raw Materials & Stability Associate

The Quality Control Raw Materials and Stability Associate will support the quality control function through coordination, documentation, and data review activities for raw materials and stability programs in accordance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. This role does not involve routine bench work but instead focuses on ensuring that testing activities, data integrity, and quality documentation meet internal specifications and regulatory standards. The associate will coordinate raw material testing with contract testing laboratories (CTLs), review and summarize externally generated data to support material release, and assist in the qualification of critical ancillary materials and excipients used in GMP manufacturing. For stability, this individual will schedule and review testing activities for T-Cell final product and author internal summaries of stability data as needed.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• 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.
• Assist in data integrity checks.
• Assist in program improvements such as design/implantation of templates within LIMS.
• Assist in the qualification of critical ancillary and excipient raw materials used in the GMP manufacturing process.

QUALIFICATIONS:

REQUIRED:

• 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.
• Ability to work independently on assigned projects with limited supervision.
• Experience coordinating with external testing laboratories.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet.

Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.