QC Scientist III - Microbiology
About The Position
As a QC Scientist III at Thermo Fisher Scientific, you will be a vital part of a collaborative team dedicated to making the world healthier, cleaner, and safer. This role involves performing diverse microbiological, chemical, and physical testing to ensure the safety and efficacy of pharmaceutical products, adhering strictly to Good Manufacturing Practices (GMP). You will work with advanced analytical instruments in a dynamic environment that fosters continuous learning and career advancement, contributing to the delivery of vital therapies to patients. Beyond testing, responsibilities include data review, troubleshooting technical issues, and providing oversight to junior staff. Key tasks also encompass executing and reviewing tests for product release, stability, and in-process samples, authoring and reviewing technical documentation, participating in quality records investigations, and interacting with clients and regulatory authorities. Your contributions will directly impact patient safety and product quality while advancing scientific innovation.
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
- 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
- Ability to wear PPE and work in laboratory environments
- Strong attention to detail and problem-solving skills
- Experience mentoring team members
Nice To Haves
- Knowledge of Pharmaceutical Regulatory Guidance (FDA and EMA)
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
Benefits
- Excellent Benefits Package
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off & Holidays
- 401K Company Match up to 6%
- Tuition Reimbursement – eligible after 90 days!
- Employee Referral Bonus
- Employee Discount Program
- Recognition Program
- Charitable Gift Matching
- Company Paid Parental Leave
- Career Advancement Opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
