Quality Control Analytical Associate

• Perform routine and non-routine analytical testing of in-process samples, and finished products in accordance with approved SOPs.
• Accurately record all test data, observations, and results in laboratory notebooks and LIMS in real time.
• Prepare reagents per approved SOPs; maintain accurate preparation logbooks.
• Perform instrument calibration checks and coordinate with the Maintenance team for scheduled PMs.
• Maintain laboratory cleanliness, safety, and GMP/GLP compliance.
• Receive, log, and label incoming samples; maintain chain of custody documentation.
• Manage QC sample inventory including reference standards, reagents, and consumables using ERP/LIMS.
• Monitor expiry dates for reference standards and reagents; initiate replenishment requests proactively.
• Perform physical inventory counts, reconcile discrepancies, and maintain a GMP-compliant storage environment.
  
  

• 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.

• Experience with technical writing such as authoring/revising SOP's, study protocols and reports, specification, Certificate of Analysis, etc.
• Familiarity with flow cytometry, ELISA, Endotoxin testing, cell-based potency assays and sterility testing
• Understanding of inventory management principles in a regulated setting.
• Ability to work independently on assigned projects with limited supervision.

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.