Senior Quality Operations Specialist I

About Made Scientific

Made Scientific is a U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors.

We’re growing and looking for a Senior Quality Operations (QO) Specialist.

This is a hands-on role on the floor, supporting manufacturing, reviewing GMP documentation, and making sure the work meets the standard every time.

We're looking for someone with strong judgment, who thrives in the pace, stays locked in on the details, and takes real ownership of their work. You should be comfortable stepping in, asking questions, and following things through.

Work Schedule Requirement

This role operates on a Wednesday–Sunday schedule, 1st shift (7:00 AM – 5:00 PM).

Key Responsibilities

Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements including but not limited to:

Quality Oversight & Compliance

• Provide on-floor Quality Operations (QO) support for manufacturing, warehouse, and other technical operations, including in-process checks, deviation identification, and adherence to cGMP expectations.
• Ensure all manufacturing activities comply with GMP and regulatory requirements.
• Review and approve GMP documentation (e.g., batch records, SOPs, test methods, validation protocols, technical reports) for accuracy and compliance.
• Execute product-related activities, including apheresis material receipt, raw material disposition, production document issuance, batch review, and final product disposition and shipment.
• Ensure timely resolution and escalation of quality issues to support lot closure and product release.

Investigations & CAPA

• Lead and drive investigations into deviations, non-conformances, environmental excursions, and process anomalies.
• Review and approve deviations and CAPAs, ensuring robust, timely, and compliant resolution.
• Apply structured root cause analysis tools such as 5 Whys, Fishbone (Ishikawa), FMEA, and other risk-based approaches to support investigations and ensure thorough, compliant, and timely investigations.

Collaboration & Communication

• Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams to resolve quality issues.
• Represent the Quality Operations department in team discussions and project meetings.
• Keep management informed of progress, issues, and needs to ensure smooth execution of GMP Operations and quality-related activities.
• Partner with internal stakeholders and external customers to address quality concerns and propose compliant, risk-based solutions.

Continuous Improvement & Audits

• Support continuous improvement initiatives to enhance quality, compliance, and operational efficiency.
• Participate in and support internal audits, facility walkthroughs, and regulatory inspections.
• Proactively notify management of risks, identify and help implement process improvements based on root cause trends and investigation outcomes.
• Perform additional duties as required to support departmental goals.

Required Qualifications

• Bachelor’s degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry. 3-5 years of QA experience in a GMP-regulated environment, ideally with cell therapy, gene therapy, or other advanced biologics; CDMO experience strongly preferred
• Strong knowledge of batch record review, aseptic operations, and environmental monitoring and cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA guidance.
• Demonstrated ability to lead and close complex quality investigations, including root cause analysis and development of effective CAPAs.
• Proficient in investigation tools and methodologies such as Fishbone diagrams, 5 Whys, FMEA, and other risk-based quality tools.
• Excellent problem-solving skills, with a focus on risk-based decision-making and continuous improvement.
• Work independently on routine tasks.
• Strong knowledge of quality and risk management principles.
• Ability to understand technical concepts and make informed quality decisions in clinical manufacturing.
• Willingness to work in ISO 7 environments for on-the-floor QA support.
• Proactive, adaptable, and committed to continuous learning.
• Ability to manage multiple priorities and thrive in a dynamic environment.
• Flexibility to travel between facilities and work varying hours, including evenings, weekends, and shifts as needed.
• Highly organized, team-oriented, and able to work independently with a positive attitude.
• Strong verbal and written communication skills, with some experience interacting with clients and health authorities.

Preferred Qualifications

• Knowledge of GMPs and ability to apply them in compliance with U.S., EU, and ROW standards.
• Knowledge of cell and gene therapy products, especially in clinical production.
• Experience with electronic quality management systems (e.g., Veeva) is a plus
• Demonstrated ability to lead investigations and support deviation and CAPA processes.
• Working knowledge of aseptic manufacturing and contamination control strategies.
• Strong negotiation and collaboration skills to support cross-functional problem-solving.
• Innovative mindset and the ability to adapt best practices in a scaling or evolving environment.
• Exceptional attention to detail, organizational skills, and the ability to thrive under pressure.

Preferred Degree

B.S. degree in relevant area

Physical Requirements

Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for a CNC/ISO8/ISO7 facility, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.