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QC Associate I
2 months ago
Join Minaris Regenerative Medicine, a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We are seeking a highly motivated and detail-oriented QC Analytical Associate I to support our clinical and commercial production teams.
Job SummaryThe QC Analytical Associate I will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. This role will perform accurate execution of all company and/or client test methods and procedures of cellular products, maintain equipment, and troubleshoot issues.
Key Responsibilities- Perform analytical testing and document results in accordance with company and/or client procedures
- Maintain and troubleshoot equipment to ensure optimal performance
- Participate in managing QC materials and supplies
- Assist in equipment and method qualification/validation activities
- Prepare reagents and media
- Investigate out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
- Initiate and prepare deviation reports
- Communicate effectively with other co-workers, departments, management, and clients
- BA/BS in a science or relevant field required
- Prior cGMP experience preferred
- Prior academic and/or industrial cell therapeutic experience preferred
- Minimum 0-2 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry
- Proficient with computer software such as Microsoft Office and Visio
- Strong written and oral communication skills
- Strong presentational skills preferred
The QC Analytical Associate I will work in a laboratory environment and be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids. The noise level in the work environment is moderately noisy.
Physical RequirementsThe QC Analytical Associate I must be able to work in a laboratory environment for an extended period and be physically capable to stand, walk, sit, bend, stretch, use hands to finger, handle or feel, reach with hands and arms, and talk or hear.
