Quality Assurance - Compliance Investigator

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

Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventive actions to ensure compliance.

Essential Functions and Responsibilities

• Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations.
• Drive investigations to true root cause using appropriate investigation tools.
• Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
• Define and manages implementation of effective preventative actions to prevent recurrence.
• Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
• Collaborate with cross-functional teams to develop and track CAPA plans.
• Identify and create appropriate trending rules that trigger corrective actions.
• Analyze process data and evaluate trends to identify major improvement opportunities.
• Effectively utilize change management approach.
• Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation process.
• Manage CAPA plans and implementation.
• Provide communication plan for on-going deviations & CAPA’s.
• Effectively create and communicate CAPA plan to responsible parties.
• Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
• Ability to abide by quality standards.
• Other duties as assigned

Competencies

• Ability to think strategically and tactically (detail-oriented)
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Analytical and problem-solving skills
• Strong written and oral communication skills
• Flexible and able to adapt to company growth and evolving responsibilities
• Integrity, accountability, and strong dedication to regulatory compliance
• Continuous improvement mindset
• Ability to work effectively as a team and independently

Qualifications

• Bachelor of Science in a Quality / Process related field or equivalent experience.
• 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Must have technical experience writing and assessing deviations, investigations, and Out of Specifications
• Must be able to analyze data/information and to assess and resolve complex problems
• Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing
• Knowledge of operational processes and controls in non-sterile and sterile operations
• Experience using e-Quality Management Systems preferred.
• Relevant IT skills (able to work with Visio, Microsoft Project and Excel)

Minimum Required Training (optional)

GMP Training as assigned
Quality Systems Training (Deviation/CAPA)
EHS Safety Training

Working Environment

• Must have the ability to work in a team-oriented environment and with clients
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
• 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. The noise level is moderate.

Physical Requirements

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

• The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
• Heavy cryo-gloves must be used when working with liquid nitrogen
• This role is sedentary. An individual may occasionally exert up to 10 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
• Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
• Must be capable of remaining in a stationary position over 50% of the time.
• 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.
• May be required to work outside of normal business hours

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.

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.