FSP - QC Reviewer: Small Molecule

JOB DESCRIPTION

Work Schedule

Environmental Conditions

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 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 activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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, and short- and long-term disability in accordance with company policy

• 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

For more information on our benefits, please visit: