FSP - QC Reviewer: Molecule

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

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

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

• 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 acceptableo Small molecule experience is preferred

• Candidates should have industry experience and not be entry-level or newly graduated without quality systems 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

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or…