Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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?

• 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.

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

• 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.

• 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).

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount