QC Analytical Associate I

Minaris Advanced Therapies • Allendale, NJ

1d • Onsite

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.
• Prior experience or certification in cGMP from an accredited program is preferred.
• A minimum of 6 months to 2 years of experience in a Quality Control laboratory or within the biopharmaceutical industry is preferred.
• 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.

Nice To Haves

• 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.

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).

Benefits

• Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level