Quality Auditor - Scientific - II (Associate)
American Cybersystems, Inc.

Job Info

Job 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, Merck 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.

Responsibilities: 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, Merck 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.

Qualifications: Skills: • 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. • 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