Quality Specialtist III (3rd Shift, Wed to Sat)

MADE Scientific Inc; Princeton (NJ); Presencial; USD 90 000 - 110 000; Tempo integral

Resumo da oferta

Made Scientific is seeking a Quality Operations Specialist III to join our Princeton, NJ team on a 3rd shift (Wed–Sat). The role provides hands-on QA oversight for GMP-regulated clinical manufacturing, ensuring cGMP compliance and timely product disposition.

The ideal candidate has 5+ years in pharma/GMP, strong CAPA and investigation skills, and the ability to lead cross-functional quality activities in a fast-paced environment.

Qualificações

• Bachelor’s degree in a scientific field with 5+ years in pharma or GMP.
• 3–5 years QA in GMP, ideally with cell or gene therapy.
• Strong knowledge of batch record review, aseptic ops, and cGMP (21 CFR 210, 211, 1271).
• Proven ability to lead investigations and develop CAPAs.
• Proficient in Fishbone, 5 Whys, FMEA, and risk-based tools.
• Ability to work independently and manage multiple priorities.

Responsabilidades

• Provide on-floor quality operations support for GMP manufacturing and related activities.
• Review and approve GMP documentation (batch records, SOPs, test methods).
• Lead deviations, non-conformances, and CAPA investigations.
• Collaborate with Manufacturing, Quality Control, and Supply Chain teams.
• Support internal audits and regulatory inspections.
• Escalate quality issues promptly to enable timely lot release.

Conhecimentos

QA experience

GMP knowledge

Investigation leadership

cGMP compliance

Root cause analysis

Formação académica

Bachelor's degree

Ferramentas

Veeva

Descrição da oferta de emprego

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Specialtist III (3rd Shift, Wed to Sat)

FT - Non-Exempt Princeton, NJ, US

2 days ago Requisition ID: 1013

Quality Operations Specialist III

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

We are seeking a Quality Operations Specialist III to join our team. This is a full-time, onsite position based in Princeton, New Jersey, reporting to the Quality Operations Supervisor. This position is currently a 3rd shift position that works Wed-Sat.

Position Summary

The Quality Operations professional provides hands-on Quality Assurance oversight and support for GMP-regulated clinical manufacturing and technical operations, ensuring compliance with applicable cGMP requirements, regulatory expectations, and company quality standards. This role is responsible for on-floor quality support, GMP documentation review and approval, batch record

Key Responsibilities

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.
• 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.
• 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.

Physical Requirements

• Ability to perform the essential job functions consistent safely and successfully with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state, and local standards.
• Must be willing to be gown qualified and work in BSL-2 lab/CNC/ISO7/ISO8 facility.
• Must be able to lift and carry up to 30 lbs.
• Must be willing to bend, stoop, carry, reach, climb or stand on an elevated bench or step stool.
• Must be willing to sit or stand for extended periods.
• Must be willing to work with cell-based products, chemicals or hazardous materials.
• Work is performed in a combination of manufacturing, laboratory, warehouse, mechanical, and office environments.
• May work around manufacturing equipment, mechanical systems, chemicals, and hazardous materials.
• Required to wear appropriate personal protective equipment (PPE) and follow applicable safety and GMP requirements.
• May require occasional work outside of normal business hours to support maintenance needs or facility emergencies.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Equal Employment Opportunity Statement

Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law.

Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.