Quality Auditor - Scientific - II

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 escalate 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.