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, *** 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.
Quals--
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