Associate Scientist - QC Reviewer

at  Thermo Fisher Scientific

JOB DESCRIPTION

Associate Scientist – QC Reviewer
Location: Middleton, WI, Fully Onsite in Office
Department: Bioanalytical
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.
Discover Impactful Work:
Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.

A day in the Life:

• Perform daily review of chromatographically based data, including electronic files, chromatograms, forms, and documentation.
• Ensure accuracy, consistency, and completeness of all reviewed materials.
• Collaborate with cross-functional teams to identify and resolve any discrepancies or issues.
• Strictly adhere to quality control (QC) standards and guidelines.
• Determine and implement corrective actions to maintain the highest level of data integrity.
• Successfully compete assigned tasks within specified deadlines.

Keys to Success:

EDUCATION

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification

EXPERIENCE

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years).
  In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role.

KNOWLEDGE, SKILLS, ABILITIES

• Proven experience in QC review of chromatographic data, forms, and documentation.
• Strong attention to detail and exceptional organizational skills.
• Excellent problem-solving abilities.
• Ability to effectively communicate and collaborate with colleagues at all levels.
• Knowledge of applicable regulatory authority, compendia and ICH guidelines
• Knowledge of routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guideline.
• Excellent manual dexterity skills
• Good written and oral communication skills
• Time management and project management skills
• Proven problem solving and troubleshooting abilities
• Ability to cross-train on sample preparation techniques with another laboratory group
• Ability to work in a collaborative work environment with a team

• 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