FSP - QC Reviewer: Small Molecule
About The Position
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
Requirements
- 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
- Solid understanding of: Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Quality Systems concepts
- Hands-on laboratory experience, preferably in a small molecule environment
- Candidates should have industry experience and not be entry-level or newly graduated without quality systems experience
- 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
Nice To Haves
- Large molecule/biologics experience is acceptable
- Small molecule experience is preferred
- 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
Responsibilities
- 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
- Review QC data and documentation
- Support quality system activities
- Assist with report writing and documentation reviews
- Ensure compliance with applicable GDP and GMP requirements
Benefits
- competitive remuneration
- annual incentive plan bonus
- healthcare
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO)
- 10 paid holidays annually
- paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
- accident and life insurance
- short- and long-term disability
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
