Quality Auditor II: Batch Records & Compliance

WorkLLama; Rahway (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

WorkLLama is seeking a Quality Assurance contractor to support GDQ Ops, ensuring cGMP compliance, batch disposition, and quality documentation for clinical-stage drug products. The role involves independent review of batch records and investigations in a fast-paced R&D environment.

Ideal candidates have a Bachelor's in a related science and at least 3 years in regulated industries, with familiarity in SAP or Veeva and strong project management.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, Biochemistry, Microbiology, or another related scientific discipline.
• Minimum of 3 years of relevant industry experience preferred; recent graduates may be considered if experienced candidates are not available.
• Experience working within pharmaceutical, biotechnology, medical device, chemical, or other regulated industries.
• Knowledge of GMP regulations, quality systems, and regulated manufacturing environments.

Responsibilities

• Perform independent quality review and approval of executed batch records, testing data, and supporting documentation for product release activities.
• Conduct batch disposition activities and make release or rejection recommendations in accordance with quality procedures.
• Review and approve quality documents including deviations, investigations, analytical method validations, method transfers, specifications, COAs, and other GMP-related records.

Skills

Quality review

Batch disposition

Documentation

GMP knowledge

Project management

Communication

Independent work

Education

Bachelor's degree in a related field

Tools

SAP

Veeva

Job description

WorkLLama is seeking a Quality Assurance contractor to support GDQ Ops, ensuring cGMP compliance, batch disposition, and quality documentation for clinical-stage drug products. The role involves independent review of batch records and investigations in a fast-paced R&D environment.

Ideal candidates have a Bachelor's in a related science and at least 3 years in regulated industries, with familiarity in SAP or Veeva and strong project management.