Quality Control - QC Analytical Associate I

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 I 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. Essential Functions And Responsibilities Under the direction of the QC supervisor or manager, responsibilities of the QC Analytical Associate I will include but are not limited to: 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). Knowledge, Skill & Ability 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. Education & Experience Bachelor’s degree in scientific discipline or a relevant field is required. 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. Quality Requirements 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. Working Environment Employee will work with moderate noise levels. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off‑shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills. Physical Requirements 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. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. 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. Special Working Conditions May require occasional overtime, weekend, or holiday work to support critical testing deadlines or production schedules. Exposure to moderate noise levels and potential biohazardous materials; strict compliance with safety and biosafety procedures is mandatory. May be required to participate in periodic extended shifts during critical operations or investigations. Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice. Estimated Salary The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. 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. #J-18808-Ljbffr