Associate Scientific Quality Auditor – II

Job Description

Job Summary:

• 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 policies, and procedures.

Duties and 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, 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.

Education and Experience:

• Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology).
• Minimum of 1 year experience preferred. Recent graduate can be considered.
• Experience should be in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry.
• 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.

Knowledge, Skills and Abilities:

• Knowledge of R&D or clinical supply areas and processes.
• 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.