Senior Specialist, Quality Assurance

Perform quality assurance activities related to API manufacturing in a complex, clinical supply development Review and/or approve GMP documents Ensure all API manufactured in compliance with cGMP and regulatory filings 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, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc. Accountable for all assigned projects and communication of status to the Management Team Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels Establish, educate, and enforce standard operating procedures (SOPs) required under GMP Develop/update SOPs to ensure practices are accurately reflected Assist in SOP and quality-related system document approval Support metrics by summarizing findings during documentation reviews Collect, prepare and analyze data to support quality system metrics and planning Support compliance activities such as site readiness, audits, inspections, and CAPAs Support quality risk management activities as facilitator, project lead and/or quality subject matter expert Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency Support the implementation of the clinical supply QMS through participation as topic team member and/or subject matter expert Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables Exercise broad judgment in making quality decisions and solving complex problems Escalate issues as needed Provide meeting coordination, facilitation, scribing, and communication. Requirements Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology) Minimum of 5 years’ experience with a B.S. Experience in the pharmaceutical or closely related industry Experience in one or more functional areas such as quality assurance, analytical laboratories, manufacturing, production support area, equipment/facilities management, regulatory GMP or related drug regulation knowledge and expertiseStrong leadership, collaboration, teamwork, negotiation, communication, problem-solving and workload management skills Excellent verbal and written communication including presentation skills Demonstrated ability to manage projects, priorities, to meet deliverables and timelines Attention to detail, flexibility, and an awareness of production and associated quality problems Ability to work in a dynamic environment with rapidly changing needs 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. Core Competencies Demonstrates expertise in quality assurance and compliance within the pharmaceutical industry, with a strong focus on cGMP practices, project management, and effective communication across cross-functional teams. Highest-signal resume keywords Quality Assurance CGMP Compliance Project Management Analytical Method Validation Leadership ATS Optimization Keywords Hard Skills Quality Review Batch Record Approval Document Auditing SOP Development Data Analysis Soft Skills Collaboration Problem-Solving Communication Negotiation Attention to Detail Industry Keywords Pharmaceutical Industry Regulatory Compliance Quality Management System CAPA GMP Documentation Tools & Technologies Microsoft Suite Electronic Systems #J-18808-Ljbffr Jobtailor