Pharmaceutical Quality Assurance

Job Title: Pharmaceutical Quality Assurance

Location: Summit, NJ 07901

Duration: 6 Months

Pay Rage : $55/hr. – $58/hr. on W2 (No Benefits)

Work Arrangement: 100% Onsite

Job Overview:

The Scientist/Engineer will lead manufacturing and QC investigation reports in support of CAR T operations. Responsibilities include conducting thorough root cause investigations, interviewing personnel, hypothesis testing, report writing, identifying corrective and preventive actions (CAPA), and troubleshooting complex issues. This role collaborates closely with various functional teams, including Quality Assurance.

Key Responsibilities:

• Conduct and lead deviation investigations (OOS, OOT, Environmental Monitoring, etc.) using root cause analysis tools.
• Author and manage investigation reports, ensuring timely closure.
• Perform GEMBA walks with stakeholders to understand process steps and assess root causes.
• Develop and implement effective CAPAs, ensuring compliance and effectiveness.
• Assess impact and risks of process changes and develop mitigation strategies.
• Support audits and inspections by health authorities.
• Initiate and manage change control documentation as needed.
• Provide technical support for investigations, CAPAs, and change controls.
• Train new team members on investigation processes.
• Apply lean manufacturing and Six Sigma principles for continuous improvement.

Required Skills & Competencies:

• Experience in deviation investigations using root cause analysis tools.
• Strong knowledge of CAPA processes and effectiveness verification.
• Excellent technical writing and collaboration skills.
• Ability to interpret and apply Global Regulatory and cGMP requirements.
• Experience with data trending, statistical analysis, and electronic Quality systems (e.g., eQRMs).
• Hands-on experience in CAR-T or biopharmaceutical manufacturing and Quality Control preferred.
• Strong problem-solving skills and ability to manage changing priorities.
• Effective communication with stakeholders across various levels.

Education & Experience:

• Bachelor’s degree in science or engineering (Biochemistry, Life Sciences, or related field preferred; advanced degree is a plus).
• Minimum of 3 years of relevant experience in a regulated environment.
• Experience in biopharmaceutical manufacturing preferred (CAR T is a plus).
• Equivalent education and experience may be considered.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.