Job Description QC Scientist II
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day enabling our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe, or helping find cures for cancer.

EDUCATION:

• Minimum required education: Bachelor’s degree in microbiology, biology, and/or chemistry.

EXPERIENCE:

• A minimum of 3+ years within a GMP laboratory and/or Quality Control laboratory required.
• Direct experience of 1-3 years within cell therapy, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Extensive knowledge of general and specific Quality Control analytical testing principles, as applicable to focus of position (e.g., raw materials, chemistry, bioanalytical, microbiology, etc.).
• Knowledge of cGMP practices, multicolor flow cytometry, cell culture, qPCR, ddPCR, immunoassay, mycoplasma testing etc.
• Ability to demonstrate familiarity with aseptic techniques and practices
• Knowledge of industry standards such as ISO, ICH, FDA and USP preferred
• MS Office (Word, Excel, Power Point, etc.)
• Strong attention to detail - results driven and motivated
• Investigation and experience with Root Cause Analysis is preferred
• Knowledge and basic understanding of 5S and LEAN principles is preferred
• Able to thrive working independently and optimally collaborate and contribute as part of a team
• Strong technical writing with the ability to build, use, and interpret scientific tables, charts, and graphs.
• Knowledge of testing and associated equipment protocols and requirements and analytical/microbiological testing instrumentation.
• Strong interpersonal and communications skills; written and oral.
• Participate and provide input on timelines, potential compliance issues and other related QC activities.
• Able to read, comprehend, and make appropriate alterations to documents such as method protocols, batch records, quality agreements, SOPs, etc
• Ability to function in a constantly evolving and continuously improving environment and balance multiple priorities simultaneously
• Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software and Laboratory Information Management System (LIMS) software), including software programs generating reports and statistics.
  As an organization of over 100,000 global colleagues, sharing a common set of 4i values - Integrity, Intensity, Innovation and Involvement - and unified vision of working together to accelerate the progression of research, tackle and resolve complex scientific challenges, drive technological innovation, and continuously support patients in need.
  

  StartYourStory at Thermo Fisher Scientific, where diverse experiences, multifaceted backgrounds, and different perspectives are valued and encouraged.

• Assist in all Department functions, such as routine testing, environmental monitoring, inventory control, equipment operation, logbooks, and data maintaining Good Documentation Practices (GDP)
• Interpret data results in accordance with concepts of biology, microbiology, industry standards, site SOPs and policies. Ensure data results meet product specifications.
• Participate in investigation/RCA for related OOS’s/investigations.
• Complete preventative maintenance of instruments and equipment, ensuring compliance and work notifications tasks are completed on time.
• Perform method qualifications and testing of in-process, final drug product, stability samples, and raw materials.
• Author and collaborate on SOPs, test forms, protocols, and reports.
• Ensure tasks are performed with a method of prioritization - effectively interpret production schedules and complete tasks accordingly.
• Identify deviations and aid in investigations. Work to complete documentation of exceptions, deviations, and events in appropriate systems
• Ensure testing is performed in an accurate and timely manner to meet production schedule and project timelines
• Participate in shift exchanges, 1-1’s, department meetings, attend internal and external client meetings as required to facilitate area needs based on changes, etc.
• Practice effective and efficient listening and observation skills
• Maintain detailed record keeping and thorough documentation to ensure readiness to support any laboratory investigations
• Demonstrate good verbal and written communication skills.
• Show the ability to build rapport with teammates and other departments and maintain strong respectful and professional working relationships supporting the collaborative environment of the site
• Possess the ability to work well independently and in a team-oriented environment with limited supervision
• Possess a growth mindset and contribute to the fostering of a healthy work environment taking the initiative to promote the growth and development of yourself and others
• Approach tasks and assignments with a positive and open-minded mentality