Participate on the project team as a subject matter expert around process design/qualification Investigate NCMR/CAPAs Write, review, and complete process validations Ensure product requirements are being met through the design of the process Analyze information and come to conclusions based on presented data Present results in a logical and clear manner EXPERIENCE Minimum

Solve challenging workplace problems Learn and become system owner of support systems Prepare documents to include maintenance, quality, production, and reports Communicate status of work assignments as requested Support workplace continuous improvement projects Interact with plant functions (quality, production, facilities, purchasing, validation, tech services, etc.) to

Identify, manage, and perform internal/external GCP audits Write, review, and approve GCP documents (agreements, plans, and reports) Perform and/or oversee internal/external GCP quality investigations to ensure that issues are thoroughly evaluated and appropriate actions are taken Provide GCP guidance to ensure compliance with applicable regulations Innovate processes and

Oversee routine study sample management operational activities Track clinical trial samples from sample receipt to result reporting to investigator sites and/or external collaborators Escalate cases with no movement in lab processing or logistical sample return issues to Study or CTS Lead Monitor incomplete specimen sets and provide timely resolution of aging cases beyond

Identify, develop, and maintain relationships with thought leaders Collaborate cross functionally to contribute to scientific communications/publications plan Develop a medical education plan by identifying gaps in current knowledge and apply deep therapeutic area insights to action Lead MSLs in delivering timely, objective, scientific, and economic information/education

Interact with both internal/external stakeholders to ensure compliance of preclinical studies to the GLP regulations (21 CFR Part 58) and internal procedures Participate in the development, implementation, and maintenance of various aspects of the internal Quality System Create and review documents (SOPs, Procedures, Methods, Protocols, etc.) in overall support of continu

Lead the statistical and programming activities in ISS/ISE to support BLA Perform, advise, and review protocol development, sample size calculation, protocol, and CRF review Ensure the accurate programming of SAS clinical data extracts and data displays Provide statistical input into and perform review of SAPs, table shells, programming/table specifications, TLFs, and sta

The QA Specialist Product Complaints is responsible for ensuring compliance of the Product Quality Complaint (PQC) process as well as participating in additional aspects of the post market surveillance program. This role will initiate incoming Product Complaints, lead and/or facilitate investigations both at client and at Contract Manufacturing Organizations (CMOs), and w

OVERVIEW Advanced Clinical is currently recruiting on the behalf of a Chronic Disease Pharma based company in the East Bay Area, California they are seeking an experienced In House CRA/Senior CRA. This role will be working within a small start up environment directly with Clinical Trial Managers and the Director of Clinical Operations as an individual contributor. Apply t

Arrange and coordinate domestic and international travel, meetings, conference calls, and related scheduling (including last minute changes) Complete and submit complex expense reports, word processing of letters, contracts, and other documents Manage and coordinate vendor invoicing, telephone coverage, faxing, scanning, and photocopying of documents Process and distribut

Develop an understanding of the regional landscape including specialties involved in care of patients Generate and execute tactical regional plans to provide need based, value added support of the medical/scientific community in line with company goals Support clinical development initiatives Collaborate with key internal/external stakeholders on Medical Affairs initiativ

Maintain all qualified equipment systems in compliance with policies, guidelines, and procedures Contribute to change controls, validation plans, qualification protocols, associated reports, and procedures Author, review, and/or execute qualification/validation protocols Execute qualification and/or validation of equipment, process control systems validation (CSV), cleani

Maintain operational readiness of cGMP automation systems Collaborate with manufacturing/other end users to develop functional requirements, implement necessary changes, and improve the automation system's overall reliability/efficiency Design, implement, and test automation solutions/strategies based on functional requirements and change control management processes Supp

Serve as the lead Quality representative for the product transfer process, including design input, design V&V activities, design transfer, and product realization Verify all design requirements are effectively met Support cross functional engineering teams with activities (design change analysis, design requirements, verification testing methods, protocols, and reports) a

Serve as a Company role model, strengthen relationships, and develop a positive team culture Plan and engineer strategies to achieve company objectives Define department goals and develop execution plans Create and manage engineering budgets Identify and lead company wide projects across multiple groups/teams Oversee a diverse team of cross functional engineers and suppor