Quality Auditor - Scientific - II (Associate)
The Quality Auditor role supports quality assurance oversight for clinical-stage drug product manufacturing and testing within a regulated GMP environment. Responsibilities include independent review and approval of batch records, certificates of analysis, investigations, and quality documents to ensure compliance and product release decisions. The position requires strong collaboration, problem-solving, and project management skills, with a hybrid work model involving onsite presence three days per week after initial training.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Position Overview
Confidential client is hiring a Quality Auditor (Scientific II / Associate) to provide GMP-focused quality oversight for clinical-stage drug product activities. This is a contractor role with a structured training period, then a hybrid schedule (required onsite days noted below). The role is based in Rahway, NJ.
What You’ll Do
- Perform independent quality review and disposition of executed batch records and associated testing data to release or reject product.
- Review Certificates of Analysis (CoA), investigations, deviations, and other regulated quality documents for completeness and compliance.
- Conduct audits/reviews of complex documents (analytical method validations, method transfers, specifications, etc.).
- Support quality system tasks: document management, record cataloging, CAPA and audit support, and site readiness activities.
- Collect and analyze data to support quality metrics and continuous improvement projects.
- Draft, edit, and review SOPs, work instructions, and other GMP-controlled documents.
- Provide meeting support (coordination, scribing, communications) and cross-functional collaboration to escalate risks and resolve issues.
- Move between different review activities while maintaining focus and accuracy to meet deadlines.
Required Qualifications
- Bachelor of Science in engineering, chemistry, biology, biochemistry, microbiology, or a related scientific/engineering discipline.
- Minimum ~3 years of experience preferred in pharmaceutical, biotechnology, chemical, medical device, or closely related regulated industries. Strong candidates with less experience may be considered.
- Demonstrated knowledge of cGMP, ICH guidelines, and regulated manufacturing/testing environments.
- Experience with batch disposition, executed batch-record review, and Certificate of Analysis review.
- Strong attention to detail, problem-solving skills, and the ability to manage multiple priorities.
- Effective written and verbal communication skills; ability to work across functions and sites.
- Proficiency with Microsoft Office (Excel, Word, PowerPoint, Teams); willingness to learn other enterprise systems.
Preferred Experience & Tools
- Previous quality-auditing, QA, or batch-disposition experience in pharmaceutical/biologics/sterile manufacturing.
- Familiarity with SAP and Veeva or comparable enterprise systems.
- Prior production-floor or “QA-on-the-floor” exposure.
- Experience reviewing investigations and complex regulated documentation.
- Scientific or engineering educational background; advanced degrees considered if aligned with experience.
Training, Schedule & Location
- Location: Rahway, NJ (onsite during initial training; hybrid afterward).
- Training: ~3 months (approx. 40% self-paced computer learning, 60% hands-on). Some qualification activities require onsite completion.
- Schedule: Fully onsite during training; transitioning to a hybrid schedule requiring 3 days onsite per week. Wednesday onsite attendance is required.
- Employment type: Full-time contractor supporting confidential client’s GDQ Ops (Drug Product) quality functions.
Skills & Competencies
- Strong organizational skills and ability to complete assignments from start to finish.
- Ability to concentrate for extended periods and maintain accuracy while switching tasks.
- Initiative, sound judgment, and appropriate escalation of questions or risks.
- Cross-functional collaboration and the ability to work with all levels of staff and management.
- Project-management capability to support continuous quality improvement projects.
Why Join (What’s In It For You)
- Hands-on role in clinical-stage drug product quality operations supporting meaningful, regulated product development.
- Structured onboarding and training with clear milestones and mentorship.
- Opportunity to grow technical and regulatory skills (batch disposition, CoA review, audits).
- Work with cross-functional teams in a regulated R&D environment, gaining exposure to manufacturing and laboratory processes.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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