QC Scientist III - Microbiology

Thermo Fisher Scientific•Greenville, NC

1d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join colleagues in bringing the Mission to life every single day to enable customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific provides 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 food is safe or helping find cures for cancer. Join our collaborative team at Thermo Fisher Scientific, where you will contribute to our mission of making the world healthier, cleaner, and safer. As a QC Scientist III, you will perform diverse microbiological testing to ensure the safety and efficacy of pharmaceutical products. You will perform chemical, physical, and microbiological analysis to support manufacturing operations while following Good Manufacturing Practices (GMP). Working with advanced analytical instruments, our collaborative environment provides opportunities for continuous learning and career advancement as you help deliver vital therapies to patients. In addition to testing, you will perform data review, troubleshoot technical issues, and provide oversight to junior staff. Your work will directly impact patient safety and product quality while advancing scientific innovation. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Requirements

Advanced Degree plus 2 years of experience, or bachelor's degree plus 5 years of experience in GMP pharmaceutical/biopharmaceutical quality control
Preferred Fields of Study: Biology, Microbiology, or related scientific field
Expertise in Compendial Microbiological testing such as Sterility, Bacterial Endotoxin Testing, Bioburden Testing and Subvisible Particulate Matter testing
Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE
Must be able to pass a comprehensive background check, which includes a drug screen
Ability to wear PPE and work in laboratory environments
Physical requirements include standing, lifting up to 25 lbs., and manual dexterity
Strong attention to detail and problem-solving skills

Nice To Haves

Knowledge of Pharmaceutical Regulatory Guidance (FDA and EMA)
Proficiency in data analysis and laboratory information management systems (LIMS)
Good technical writing and documentation skills
Strong organizational abilities
Excellent interpersonal and communication skills
Ability to work independently and work with cross-functional teams
Experience with quality investigations and CAPAs
Proficiency with Microsoft Office
Experience mentoring team members

Responsibilities

Perform diverse microbiological testing to ensure the safety and efficacy of pharmaceutical products
Perform chemical, physical, and microbiological analysis to support manufacturing operations while following Good Manufacturing Practices (GMP)
Perform data review
Troubleshoot technical issues
Provide oversight to junior staff
Execute and review tests for product release, stability, and in-process samples
Author and review technical documentation
Drive and or participate in quality records investigations
Interface with clients and regulatory authorities as needed