Quality Assurance - Compliance Investigator

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 Responsible for performing Quality Compliance and Quality System activities in support of Quality Management Systems and/or client procedures, including but not limited to, document management, investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality System management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients.

Requirements

Relevant computer skills (Microsoft Office, Outlook)
Detail-oriented and organized
Analytical and problem-solving skills
Good written and oral communication skills
Ability to multi-task and be adaptable
Flexible and able to adapt to company growth and evolving responsibilities
Ability to work independently and with a team
Strong Project Management and organization skills
Resolves and assesses a wide range of issues in creative ways and suggests variations in approach.
B.S in biological sciences or other relevant field of study.
Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
Experience in authoring, reviewing, and /or approving cGMP related documents (Investigation report, CAPA report, SOPs etc.) required.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Familiar with FDA, ISO, and other regulatory agency guidelines.
Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
Experience in both clinical and commercial manufacturing is preferred.
Experience in supporting health authority inspections and/or client audits preferred
Must have the ability to work in a team-oriented environment and with clients
Must be able to work in an office environment with minimal noise conditions.
Must be able to work in Lab setting with Biohazards /various Chemicals
Must be able to wear appropriate PPE
Must be able to work in environment with variable noise levels
Ability to stand /Sit/walk for long periods of time
Clarity of Vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures high to freezing
Inside/outside working conditions
If selected to become qualified for visual inspection, the employee must pass an eye exam including corrected or uncorrected 20/20 vision, ability to pass a color blindness test, and ability to pass a depth perception test
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.

Nice To Haves

Strong focus in the manufacturing and/or testing of biologics preferred.
Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
Experience in both clinical and commercial manufacturing is preferred.
Experience in supporting health authority inspections and/or client audits preferred

Responsibilities

Liaises with relevant functional groups (Operations, Facilities, QA, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes.
Develops and communicates investigation strategy to key stakeholders.
In order to close investigations and CAPAs, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log
Reviews and approves investigations and CAPAs;
Conducts weekly status update meetings with cross functional departments and other stakeholders.
Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis.
Prepares and issues change controls, as necessary.
Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures.
Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
Performs supplemental investigations and/or participates in project teams or assignments as necessary.
Support in agency, internal and/or client audits.
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.