FSP Scientist- QC Data Review

at  Thermo Fisher Scientific

JOB DESCRIPTION

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.
Thermo Fisher’s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
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.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
  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:

• Knowledge of US or EU cGMP regulations.
• Familiarity with processes related to batch release, OOS/OOT investigations, reference standards/assay controls, stability studies, LIMS, and raw materials testing.
• Effective communication skills, both verbal and written.
• Laboratory experience.
• Working knowledge of common compendial assays and safety testing for GMP drug products

• Performs QC review of data and ensures compliance with applicable methods, protocols, procedures, and regulatory agency guidelines
• Supports Product Release activities ensuring adherence to turn around time goals
• Evaluates data for report preparation and participates in report authorship on an as needed basis.
• Provides input and participates in project meetings, plans, monitors and guides project work
• Informs management of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems
• Participates in process improvement initiatives
• Assists with metrics for trending and reporting as required, stability and QC analytical data
• Is Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Has Exceptional communication and interpersonal skills