FSP Associate Scientist-QC Review

Thermo Fisher ScientificKing of Prussia, PA
Hybrid

About The Position

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. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. As a Scientist I your role will be to ensures the quality of laboratory data and reports while upholding the highest standards of quality and compliance in all laboratory practices.

Requirements

  • Bachelor's 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 to 1 years).
  • Knowledge of routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines
  • Knowledge of applicable regulatory authority, compendia and ICH guidelines
  • Good written and oral communication skills
  • Time management and project management skills
  • Ability to work in a collaborative work environment with a team
  • Ability to work in an upright and /or stationary position for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to office equipment.
  • Occasional mobility needed.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.

Nice To Haves

  • 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.

Responsibilities

  • Evaluate data for compliance with methods and SOPs.
  • Review sample results for completeness and accurate representation of the data and report findings.
  • Prepare QC statements noting deficiencies with the data set or notebooks. Reports deficiencies to the project leader for correction.
  • Communicate with staff to proactively address the quality of documentation.
  • Perform other duties as assigned.
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