Thermo Fishers 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.
Possesses a thorough understanding of sample management processes and works closely with scientists and project managers to ensure samples are received and transferred in accordance with SOPs and study protocols. Develops independence in performing routine work and ability to organize, manage and set priorities for multiple tasks. Demonstrate the ability to document according to ALCOA documentation practices, communicate observations and escalate issues effectively.
- Works with multiple functional groups to meet business needs.
- Performs work assignments accurately, and in a timely and safe manner.
- Plans and organizes work with periodic supervision.
- Safely works with biological matrix (e.g. plasma, urine, blood, CSF, etc) in a biohazard level 2 laboratory.
- Log shipments and receive samples for clinical and/or toxicology trials, in accordance with priority and in accordance with SOPs and regulations.
- Document and maintain shipment, sample receipt and condition records per SOP.
- Notify manager and sample owner (i.e. scientist) of any abnormal receipt conditions.
- Performs self and peer review of the data for accuracy and compliance.
- Maintain sample integrity and chain of custody and report any concerns or failures on time.
- Ensure compliance with current SOPs and training.
- Support QA audits and ensures QA findings are addressed appropriately.
Qualifications – External
Education and Experience:
- Bachelors degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2+ 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 applicable regulatory requirements
- Ability to understand and independently apply GLPs to everyday work
- Ability to utilize Microsoft Excel and Word to perform tasks
- Ability to use electronic laboratory notebook and Laboratory Information Management System (e.g. Watson LIMS, StarLIMS, etc)
- Good written and oral communication skills
- Time management and project management skills
- Problem solving and troubleshooting abilities
- Ability to work in a collaborative work environment with a team
- Strong organization, attention to detail, and multi-tasking skills
PPD, part of Thermo Fisher Scientific values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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.
- As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!