Quality Assurance - Compliance Investigator

Minaris Advanced Therapies•Allendale, NJ

2d•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 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.

Requirements

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
Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
GMP Training as assigned
Quality Systems Training (Deviation/CAPA)
EHS Safety Training
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
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.

Nice To Haves

Experience using e-Quality Management Systems preferred.

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