Quality Control Specialist - Raw Materials at Thermo Fisher Scientific in Boston, Massachusetts

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards



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.




Key responsibilities:

• Perform testing of in-coming raw materials, consumables, and gases


• Perform samplings and visual inspections


• Manage shipment of samples for tests performed at contract testing laboratories


• Experience in compendial methodology and multiple analytical techniques: IR, H(U)PLC, Gas Chromatography, LC/MS, UV-Vis, Osmolality, pH, microscopy


• Assist management with quality event records (change controls, investigations, deviations, CAPAs)


• Key contributor for external test labs to develop analytical methods suitable for testing critical material attributes for raw materials


• Revise, review and approve supporting documentation for developed analytical methods


• Work with Quality Assurance and other key department stakeholders to revise and update internal documents such as SOPs, raw material specification docs, reports etc. on an as needed basis

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar


• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 5+years')
  


• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 3+ 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:

• Team focused, demonstrate high level of integrity, and have strong collaboration, communication, interpersonal and organizational skills


• Prior experience using FTIR, UV-Vis, LC-MS and GC-MS, Karl Fischer, Osmometer, pH meters, microscopes (nice to have).


• Experience executing USP chemical identity tests for raw materials


• Knowledge of FDA, EMA and ICH regulations, industry standards and raw material qualification for CGMP operations Experience setting up stability programs for raw materials

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! Apply Now