Quality Specialist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

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 to enable 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.
How will you make an impact?
Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. Our Cell Therapy organization within the Advanced Therapy Business Unit, is one of the fastest growing areas of Thermo Fisher Scientific. We operate a 44,000-square-foot, innovative cell therapy collaboration center on the UCSF Mission Bay campus. Opened in 2023, the facility serves as a central location where customers and UCSF researchers will have access to Thermo Fisher Scientific’s broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support to our partners. In the Cell Therapy unit, we focus on providing development and clinical/commercial scale services for gene and non-gene modified cell processing for a variety of unmet medical needs.
The QA Specialist II will provide Quality oversight for projects, performs compliance assessments, writes new procedures, and ensures adherence to current regulations. This position reports to the Quality Assurance manager.

What will you do?

• Performs batch record and QC data review for Lot disposition.
• Provides internal and external customer support.
• Supports external and internal audits.
• Has daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic techniques.
• Supports QA on the floor activities.
• Develops a quality culture by aiding personnel in understanding the application of policies and controls.
• Ensures any deviations from the norm are reported to the relevant department.
• Performs review and approval of procedures, training documents, and forms of moderate to high complexity.
• Participates as quality representative in Root Cause Analysis to support deviation investigations.
• Performs change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners.
• Maintains Quality records according to Thermo Fisher Scientific policies and procedures.
• Aids in the identification of continuous improvement opportunities.
• Participates in practical process improvement (PPI) initiatives.
• Other projects will be assigned as various business needs arise.

How will you get here?

EDUCATION

• Bachelor’s degree required in a scientific field or related field.

EXPERIENCE

• A minimum of 4 years of experience with previous experience in a Quality Assurance, Quality Control environment, or operations environment. Equivalent combinations of training and experience may be considered if at least a bachelor’s degree is acquired.
• Previous experience in a cGMP environment and Cell Therapy is preferred.

KNOWLEDGE, SKILLS, ABILITIES

• Strong critical thinking skills, with a close attention to detail and a history of good judgment
• Ability to work in a team and matrixed environment.
• Driven and resourceful, with minimal to moderate direction required.
• Ability to prioritize with good time management skills.
• Understanding of cGMP practices.
• Knowledge of regulatory guidelines: EU, US, Australian, ICH, etc.
• Change control, Deviation and investigations, root cause analysis, and risk assessment.
• Experience with SAP, TrackWise, LIMS, EDMS is preferred.
• Effective written, interpersonal, and presentation skills.
• Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint).

• Performs batch record and QC data review for Lot disposition.
• Provides internal and external customer support.
• Supports external and internal audits.
• Has daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic techniques.
• Supports QA on the floor activities.
• Develops a quality culture by aiding personnel in understanding the application of policies and controls.
• Ensures any deviations from the norm are reported to the relevant department.
• Performs review and approval of procedures, training documents, and forms of moderate to high complexity.
• Participates as quality representative in Root Cause Analysis to support deviation investigations.
• Performs change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners.
• Maintains Quality records according to Thermo Fisher Scientific policies and procedures.
• Aids in the identification of continuous improvement opportunities.
• Participates in practical process improvement (PPI) initiatives.
• Other projects will be assigned as various business needs arise