QC Analytical Associate I
3 days ago
Job Title: Quality Control Analytical Associate I
Location: Mahwah, NJ area
Schedule: 2nd Shift, Sunday-Thursday (2:30 pm to 11 pm)
Type: Contract to Hire
Responsibilities: Support clinical and commercial production through testing and quality control.
Perform process checkpoint, stability, and release analytical testing to ensure product quality.
Execute company/client test methods for cellular products to ensure safety/efficacy.
Maintain, monitor, and troubleshoot laboratory equipment.
Document and report test results following cGMP and GTP guidelines.
Participate in proficiency testing, equipment validation, and reagent/media preparation.
Investigate out-of-spec results and prepare deviation reports.
Implement corrective actions and document compliance with SOPs, cGMP, and GDP.
Communicate with teams, departments, and clients as needed.
Requirements: Education: BA/BS in Science or related field.
Experience: 0-2 years in Quality Control or biopharmaceutical industry; cGMP experience preferred.
Skills: Familiarity with lab equipment (cell count, flow cytometry, CBC).
Proficient with Microsoft Office and Visio.
Strong written and oral communication skills.
Prior experience with cell therapeutic work preferred.
Compliance & Regulatory: Ensure adherence to FDA and global quality regulations.
Attend required Quality & Compliance training.
Benefits: Health, dental, and vision insurance options.
401(k) participation and life insurance.
Keywords: "GTP", "Good Tissue Practices", "Good Documentation Practices", "GDP", "cell therapy", "cell therapeutic", "cellular products", "cell count", "flow cytometry", "CBC", "basic laboratory equipment"
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