Aptask Global Workforce (AGW) is seeking a Quality Auditor - Scientific - Onsite position with a Pharmaceutical Company located in Rahway, NJ. This is a 23+ month contract opportunity. This role provides Quality oversight for manufacturing, testing, and release activities associated with clinical-stage Drug Products. The contractor will be responsible for quality assurance oversight, performing diverse tasks, and participating in quality-related projects to ensure compliance with applicable GMP regulations, ICH guidelines, and company policies and procedures.
Responsibilities: - Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product
- Make independent batch release or reject decisions
- Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, analytical method validations, and specifications
- Collect, prepare and analyze data to support quality system metrics and planning
- Perform document management activities such as cataloging records for long term document storage according to retention policies
- Support compliance activities such as site readiness, audits, and CAPAs
- Support quality risk management activities and projects for continuous quality improvement
- Develop, write, technically edit, or review procedures or other standards documents under GMP
Requirements: - Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology)
- Minimum of 3 years of experience in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry
- Experience in batch disposition and batch release
- Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, or production
- Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise
- Knowledge of R&D or clinical supply areas and processes
- Strong leadership, collaboration, teamwork, negotiation, and communication skills
- Demonstrated ability to manage projects and priorities to meet deliverables and timelines
- Proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams) and ability to adapt to learning other electronic systems (e.g., SAP and Veeva)
Pay Range: up to $39.27 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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