QA Change Control Specialist – Cell Therapy

Legend Biotech; Raritan (NJ); On-site; USD 81,273 - 106,669; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company match

Paid parental leave

Flexible spending and health savings accounts

Peer-to-peer recognition programs

Job summary

A biotechnology company in New Jersey seeks a QA Change Control Specialist II responsible for quality oversight in a cell therapy manufacturing facility. Applicants should possess a Bachelor's degree in Science and a minimum of two years' experience within a cGMP environment. Strong communication, analytical problem-solving, and attention to detail are essential. This role offers a competitive salary, excellent benefits, and the chance to work within a collaborative team focused on cutting-edge therapies.

Qualifications

• Minimum of 2 years of relevant work experience in a cGMP manufacturing facility.
• GxP Quality System knowledge and relevant regulations (e.g., 21 CFR, ICH Q10).
• Experience in quality metrics reporting and process improvement techniques.

Responsibilities

• Support and streamline the site change control process.
• Manage change control activities throughout the lifecycle.
• Collaborate with functional departments to resolve issues.

Skills

Strong written and verbal communication skills

Analytical problem-solving

Attention to detail

Flexible and highly motivated

Education

Bachelor’s Degree in Science or equivalent

Tools

Microsoft Office

Electronic quality systems

Job description

A biotechnology company in New Jersey seeks a QA Change Control Specialist II responsible for quality oversight in a cell therapy manufacturing facility. Applicants should possess a Bachelor's degree in Science and a minimum of two years' experience within a cGMP environment. Strong communication, analytical problem-solving, and attention to detail are essential. This role offers a competitive salary, excellent benefits, and the chance to work within a collaborative team focused on cutting-edge therapies.