Quality Control - QC Analytical Associate I

Minaris Advanced Therapies•Allendale, NJ

About The Position

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market. At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time. Position Summary The Quality Control Analytical Associate serves as a support role in clinical and commercial production. The 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.

Requirements

Proficient in computer software including Microsoft Office (Word, Excel, PowerPoint) and Visio for documentation and process mapping.
Communicates effectively with co-workers, cross-functional teams, management, and clients, both verbally and in writing.
Strong written and oral communication skills, able to prepare clear and concise reports and documentation.
Detail-oriented with the ability to multitask efficiently in a fast-paced, team-oriented environment.
Flexible and adaptable to changing priorities, company growth, and evolving job responsibilities.
Bachelor’s degree in scientific discipline or a relevant field is required.
Comply with all applicable FDA, EU, and global regulatory requirements and cGMP standards relevant to QC laboratory operations.
Follow established SOPs, protocols, and quality system procedures rigorously to ensure accuracy and reliability of test results.
Maintain strict data integrity by documenting all laboratory activities accurately, completely, and in a timely manner.
Participate actively in training programs to stay current with quality standards and best practices.
Support audit readiness by ensuring proper documentation and laboratory cleanliness as required.
Report any deviations, non-conformances, or quality concerns promptly to supervisors.
The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
May work with hazardous materials and chemicals
Gowning Proficiency as needed.
The work environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have sufficient vision to read materials.
Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.

Nice To Haves

Prior experience or certification in cGMP from an accredited program is preferred.
Previous academic and/or industrial experience in cell and gene therapy is highly desirable. Familiarity with QC assays such as complete blood count (CBC), cell count and viability, and basic knowledge of flow cytometry is an advantage.
A minimum of 6 months to 2 years of experience in a Quality Control laboratory or within the biopharmaceutical industry is preferred.

Responsibilities

Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations
Performs maintenance, monitoring, and troubleshooting of pertinent equipment
Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP guidelines
Participates in supporting in managing QC materials and supplies
Support and assistance in equipment and method qualification/validation activities as needed
Performs reagent and media preparation as per client or general procedures
Provides input and support based on level of knowledge and experience with troubleshooting malfunctioning equipment
Perform cleanings of laboratory equipment (incubators, refrigerators, freezers, etc.,) per SOP.
Performs equipment and method qualification/validation activities as needed Support investigating out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
Support Initiation of deviations with input from QC management
Assist in managing client specific QC data and documentation on shared drive or client SharePoint sites Support
Support brainstorming and implementation of corrective and preventive actions, as and when applicable
Complete all documentation according to the written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).