Cell Therapy QA Document Control Specialist

BioSpace; Raritan (NJ); On-site; USD 70,671 - 92,757; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Flexible spending accounts

Paid parental leave

Equity and stock options

Job summary

A leading biotechnology firm in Raritan, New Jersey, is seeking a QA Document Control Specialist to support the document management process within its manufacturing facility. The ideal candidate will have a Bachelor's degree in a related field and at least 2 years of experience in quality assurance or aseptic manufacturing. This position offers a competitive salary and comprehensive benefits package including medical, dental, and paid time off.

Qualifications

• Minimum 2 years of relevant work experience in quality assurance or aseptic manufacturing.
• Knowledge of regulations such as 21 CFR and ICH Q10.
• Operational experience with electronic quality systems.

Responsibilities

• Serve as a Document Control reviewer for procedures and documents.
• Support document management system users with workflow handling.
• Manage storage and archival of GMP documents.
• Review and approve SOPs and other documentation.

Skills

Understanding of GxP quality systems

Strong written and verbal communication

Analytical and problem-solving

Organizational skills

Ability to multi-task

Education

Bachelor’s degree in Science or related field

Tools

TruVault/Veeva Document Management Systems

Job description

A leading biotechnology firm in Raritan, New Jersey, is seeking a QA Document Control Specialist to support the document management process within its manufacturing facility. The ideal candidate will have a Bachelor's degree in a related field and at least 2 years of experience in quality assurance or aseptic manufacturing. This position offers a competitive salary and comprehensive benefits package including medical, dental, and paid time off.