QUALITY AUDITOR
RAHWAY, NJ
Hybrid after training period - 3 days onsite per week.
The pay ranges between $23.00 to $26.22 per hour.
Project Description:
- The GDQ Ops - API organization provides Quality oversight for manufacturing, testing, and release activities associated with clinical-stage API.
- We provide Quality oversight of product development activities integrated with operations and functional partners, while ensuring continuous GMP-compliant clinical supply for internally and externally manufactured API.
- Under the direction of GDQ-Ops Supervision, the Contractor will be responsible for providing quality assurance oversight, performing diverse tasks, and participating in quality related projects.
- Responsibilities include the following activities: product release, quality system, compliance, document management, and any related activities needed under current Good Manufacturing Practice (cGMP).
- Ensure compliance with applicable GMP regulations, ICH guidelines, Client's policies, and procedures.
- The Contractor will support tasks that may include but are not limited to:
- 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, method transfers, analytical methods, specifications, certificates of analysis, etc.
- 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.
- Support projects for continuous quality improvement.
- Utilize project management skills as needed.
- Provide meeting coordination, facilitation, scribing, and communication.
- Develop, write, technical edit, or review procedures or other standards documents under GMP.
- Other duties as assigned by manager for the flexible functioning of the work group.
Required Skills:
- Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology).
- Minimum of 1 year experience preferred.
- Recent graduates can be considered.
- Experience should be in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry.
- Knowledge of R&D or clinical supply areas and processes.
- Preferred API knowledge and experience.
- Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, regulatory.
- Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise.
- Strong leadership, collaboration, teamwork, negotiation, communication, and workload management skills.
- Ability to work in a dynamic R&D environment with rapidly changing needs.
- Demonstrated ability to manage projects, priorities, to meet deliverables and timelines.
- Ability to work across functional and sites, with all levels of staff and management.
- Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work.
- Fully onsite during training period, transitioning to Hybrid role requiring 3 days onsite a week.
- Local candidates preferred.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Rose: Rose@alphaconsulting.com
ALPHA'S REQUIREMENT #24-00235
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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