Quality Auditor - Scientific - II; Associate Job Rahway area,New Jersey USA,Quality Assurance

Details for the position are as follows:

23 month contract to start with the possibility of extension or conversion depending on performance and business needs
Rate: $39.27 an hour
Location:

Rahway, NJ
Work Arrangement:
Hybrid – 3 days onsite per week (Wednesdays required)
Training:
Fully onsite for approximately the first 3 months, transitioning to a hybrid schedule following training

Job Description:

The Quality Assurance Specialist will support the Global Development Quality Operations (GDQ Ops) organization, providing quality oversight for manufacturing, testing, and release activities associated with clinical-stage drug products.
This position plays an important role in ensuring GMP-compliant clinical supply operations for internally and externally manufactured products. Working closely with manufacturing, laboratory, quality, and other cross‑functional teams, the individual will support batch disposition, quality documentation review, regulatory compliance, and continuous improvement initiatives.
Under the direction of GDQ Ops supervision, the specialist will perform a variety of quality assurance activities, including batch record review, product release, quality systems support, investigations, compliance, and document management, while ensuring adherence to current Good Manufacturing Practices (cGMP), ICH guidelines, and company policies and procedures.
Perform independent quality review and approval of executed batch records, testing data, and supporting documentation to determine product disposition.
Make independent batch release or rejection decisions in accordance with established procedures and regulatory requirements.
Review Certificates of Analysis (CoAs) and associated quality documentation to ensure accuracy, completeness, and compliance.
Support quality oversight of clinical drug product manufacturing, testing, and release activities.
Complete assigned quality review activities within established deadlines while maintaining accuracy and attention to detail.
Review, audit, and approve GMP‑regulated documentation, including deviations, investigations, analytical method validations, method transfers, analytical methods, specifications, and Certificates of Analysis.
Support quality system activities, including corrective and preventive actions (CAPAs), compliance initiatives, and site audit readiness.
Participate in quality risk management activities and identify potential compliance concerns.
Ensure compliance with applicable GMP regulations, ICH guidelines, and internal quality policies.
Communicate quality‑related issues, risks, and findings to appropriate stakeholders and escalated concerns when necessary.
Develop, write, review, and technically edit Standard Operating Procedures (SOPs), quality procedures, and other GMP‑controlled documents.
Maintain accurate and complete quality records, including cataloging documentation for long‑term storage in accordance with retention policies.
Collect, prepare, and analyze data to support quality system metrics, operational planning, and continuous improvement initiatives.
Participate in quality‑related projects and support process improvements across manufacturing and quality operations.
Coordinate and facilitate meetings, document discussions, and communicate action items and project updates.
Manage multiple quality review assignments and transition between different tasks while maintaining consistency, focus, and accuracy.
Perform additional responsibilities as assigned to support the operational needs of the department.

Required Skills:

Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology).
Minimum of 3 years’ experience preferred. Recent graduate may be considered…