FSP - QC Reviewer: Small Molecule

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description QC REVIEWER: At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. This role is based onsite in: Foster City, CA Key Responsibilities: Change Control Management A major focus of this role will be owning and driving change controls from initiation through closure, including: •    Writing and managing change control records •    Coordinating with Subject Matter Experts (SMEs) to gather required information •    Driving timelines, actions, and deliverables to completion (Like a Project Manager) •    Facilitating meetings and cross-functional communication when necessary •    Tracking progress and ensuring on-time closure •    Drafting final summaries, conclusions, and supporting documentation This aspect of the role requires strong organizational and project management capabilities. QC Support •    Review QC data and documentation •    Support quality system activities •    Assist with report writing and documentation reviews •    Ensure compliance with applicable GDP and GMP requirements Critical Skills •    Strong written and verbal communication skills •    Excellent organizational and project management skills •    Ability to manage timelines and follow up on action items •    Ability to work independently and drive cross-functional activities to completion •    Detail-oriented with strong documentation skills   Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job OR Masters degree In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: •    Solid understanding of:  o    Good Documentation Practices (GDP) o    Good Manufacturing Practices (GMP) o    Quality Systems concepts •    Hands-on laboratory experience, preferably in a small molecule environment  o    Large molecule/biologics experience is acceptable o    Small molecule experience is preferred •    Candidates should have industry experience and not be entry-level or newly graduated without quality systems experience Preferred Experience: •    QC review and data review experience •    Experience with change control and/or change management •    Familiarity with quality systems processes and documentation •    Experience writing reports, summaries, and technical conclusions   Working Environment: Below is listed the working environment/requirements for this role: Able to