QC Scientist III

Thermo Fisher Scientific • Plainville, MA

5d

About The Position

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. Reporting to the Plainville, MA site and supporting the Viral Vector Services (VVS), a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases. Join our collaborative team at Thermo Fisher Scientific, where you'll contribute to our mission of making the world healthier, cleaner, and safer. As a QC Scientist III, you'll perform sophisticated analytical testing and provide quality oversight for biopharmaceutical products. You'll work with advanced technology and collaborate with cross-functional teams to ensure product safety and compliance with regulatory requirements. This role offers significant opportunities to grow your expertise while supporting the development and manufacturing of life-changing therapeutics.

Requirements

• Bachelor’s degree in biological sciences, or related field required. Master's degree, or higher is highly preferred.
• 3-5 years of related experience in a GMP pharmaceutical, biopharmaceutical quality control, or regulated environment required, or 2 years with a master or higher degree will be accepted.
• Experience with quality investigations and CAPAs.
• Experience with method validation, transfer, and qualification.
• Expertise in analytical techniques such as endotoxin, bioburden, bioburden/endotoxin method suitability, plate enumeration, growth promotion, and BIs.
• Strong knowledge of FDA, EMA, ICH, ISO, and GxP regulations
• Proficiency in data analysis and laboratory information management systems
• Advanced technical writing and documentation skills
• Strong project management and organizational abilities
• Knowledge of aseptic practices, aseptic filling, contamination control, and environmental monitoring
• Ability to work independently and lead cross-functional teams
• Ability to support microbial risk assessments and root cause analysis
• Ability to wear PPE and work in laboratory environments
• May require weekend/flexible scheduling based on business needs
• Physical requirements include standing, lifting up to 25 lbs, and manual dexterity
• Strong attention to detail and problem-solving skills
• Data analysis of environmental monitoring and utility monitoring to support trending of site recoveries

Responsibilities

• You'll conduct complex analytical testing, lead method validations, perform data review, and troubleshoot technical issues.
• Executing and reviewing tests for product release, stability, and in-process samples
• Authoring and reviewing technical documentation
• Participating in investigations
• Interfacing with clients and regulatory authorities
• Your work will directly impact patient safety and product quality while advancing scientific innovation.

Benefits

• We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits!
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level