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:

　　The Quality Associate supports the Quality Function within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

　　Responsible for various aspects of quality assurance and quality control related to their functional area.

　　Ensures that product within the plant is consistently manufactured in conformance with Quality System requirements and all applicable regulatory requirements.

　　Support troubleshooting and resolution of quality compliance issues.

　　Communicates with Management for Quality Management Review, Quality Initiatives, etc.

　　Incumbent is responsible for quality decisions related to their functional area to ensure compliance with Quality Systems and cGMPs.

　　Available Schedules:

　　(Sun-Wed first shift: 6:00am-4:30pm)

　　(Wed-Sat first shift: 6:00am-4:30pm)

　　(Mon-Fri second shift: 2:00pm-10:30 pm)

　　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 to 2+ years’)

　　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:

　　2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry.

　　Familiar with use of electronic document management and laboratory information management is a PLUS

　　Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.

　　Strong communication skills, both oral and written

　　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.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Accessibility/Disability Access

　　Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

　　*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.