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QC Analytical Associate II
2 months ago
At Minaris Regenerative Medicine, we are seeking a highly skilled QC Analytical Associate II to join our team. As a key member of our quality control department, you will play a critical role in ensuring the safety and efficacy of our cellular products.
Job Summary:The QC Analytical Associate II 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 requires a strong understanding of quality control principles, analytical techniques, and regulatory requirements.
Key Responsibilities:- Perform accurate execution of all company and/or client test methods and procedures of cellular products to ensure safety and/or efficacy.
- Maintain, monitor, and troubleshoot pertinent equipment.
- Perform and assist in the training of other Quality Control technicians.
- Test, document, and report results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines.
- Participate in managing QC materials and supplies.
- Perform and assist in equipment and method qualification/validation activities as needed.
- Provide input based on level of knowledge and experience with troubleshooting malfunctioning equipment.
- Investigate out-of-specification, out-of-trend, aberrant, and/or non-conforming test results.
- Initiate, investigate, and prepare deviation reports with input from assigned supervisor.
- Brainstorm and implement corrective and preventive actions, as and when applicable.
- BA/BS in a science or relevant field required.
- Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry.
- Prior cGMP experience required.
- Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred.
- Prior industrial experience in cell count methodologies preferred.
- Prior academic and/or industrial cell therapeutic experience preferred.
- Proficient with computer software such as Microsoft Office and Visio.
- Strong written and oral communication skills.
- Strong presentational skills preferred.
- Candidate must be detail-oriented, able to multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.
The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients.
Must be able to work during the weekend, holidays, and as required by the company.
Must be able to handle the standard/moderate noise of the manufacturing facility.
Physical Requirements:The QC Analytical Associate II must be able to work in a laboratory environment for an extended period.
Must 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.
Direct reports: N/A
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
