Job Title: Quality Control Analytical Associate I (Stem Cell Therapies)
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.
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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”
