Quality Auditor - Scientific - II

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

Overview

The Global Development Quality Operations (GDQ Ops) team provides quality oversight for manufacturing, testing, and release activities supporting clinical-stage drug products. This contractor position supports Quality Assurance operations by ensuring compliance with current Good Manufacturing Practices (cGMP), ICH guidelines, company policies, and quality procedures. The role involves quality review, batch disposition, document management, compliance support, and participation in continuous quality improvement initiatives across clinical supply operations. The ideal candidate will have experience in pharmaceutical, biotechnology, medical device, chemical, or other regulated environments, with a strong attention to detail and the ability to work effectively in a fast-paced R&D setting.

Requirements

• 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.

Experience in one or more of the following areas

• Quality Assurance
• Quality Control
• Manufacturing/Production
• Laboratory Operations
• Regulatory Affairs
• Equipment or Facilities Management
• Strong understanding of batch record review, batch disposition, and quality documentation.
• Experience reviewing Certificates of Analysis (COAs), investigations, deviations, and quality records.
• Production-floor or QA-on-the-floor experience preferred.
• Familiarity with SAP, Veeva, or similar enterprise quality systems.
• Strong project management, organizational, communication, and collaboration skills.
• Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Teams.
• Ability to manage multiple priorities, work independently, and elevate issues appropriately.
• Engineering graduates are preferred; candidates with scientific degrees and aligned experience will also be considered.

Key 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
  • Certificates of Analysis
  • Other GMP-related records

Additional Information

Work Location: Rahway, NJ

Schedule: Fully onsite during the initial training period, transitioning to a hybrid schedule of 3 days onsite per week.

Onsite Requirement: Wednesday is a mandatory onsite day.

Training Duration: Approximately the first 3 months of employment.

Training Structure: 40% self-paced computer-based learning, 60% hands-on training

Contractors will be paired with trainers or experienced team members to support onboarding and qualification activities. Training includes learning company terminology, observing meetings, completing qualification tasks, and demonstrating competency before working independently. Certain qualification requirements and training activities must be completed onsite. Experienced candidates are strongly preferred; however, recent graduates demonstrating technical aptitude, initiative, problem-solving ability, and a willingness to learn may also be considered. Candidates with Master's degrees may be considered if their experience aligns with the position requirements.