QC Scientist (Assay Validation)
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.

Location/Division Specific Information

This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Discover Impactful Work:

The QC Scientist leads project tasks/activities associated with analytical method qualification, validation, verification and transfer. Specific activities include authoring/executing/review of study design, protocols and reports associated with analytical method qualification/validation/transfer to support of quality programs. You will be responsible for participating in laboratories' readiness for routine testing of but not limited to, Demo, Engineering, CTM (Clinical Trial Material), product/process validation and commercial batches manufactured.

A Day in the Life:

• Leads project with minimal supervision, manage project timelines and deliverables.
• Drives continuous improvement/Operational Excellence/innovative implementations; represent QC (method, validation, transfer) on cross functional teams; and providing guidance/training/coaching to junior colleagues; troubleshooting.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
• Coordinates action plans and contribute to executing toward team/project goals.
• Interacts with clients, presents data to clients as group representative, independently on occasion and with minimal supervision.
• Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
• Create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records; assist with protocol non-conformance evaluations.
• Build or enhance understanding of scientific discipline; supports training of staff; mentoring and coaching junior colleagues.
• Display strong investigative or technological orientation with independence for design of projects/studies and able to make significant independent contributions to the development of methodology including new technologies and automation.
• Routinely demonstrate a good practice of technical exchange and open communication with team members. Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

Keys to Success:

Education

• BS or BA degree in science or related field required.

Experience

• 1-3 years of experience in a manufacturing, quality or engineering in the biotech or pharmaceutical, or highly regulatory industry required.
• Experience in Quality Control required.
• Experience in laboratory practices, comprehensive knowledge of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories and working experience with a wide range of analytical techniques, analytical testing and use of analytical equipment required.

Knowledge, Skills, Abilities

• Ability to use Microsoft Office™ applications specifically Word, Excel, and PowerPoint.
• Lean Six Sigma concepts preferred.
• Interpersonal skills (negotiation, managing conflict) to influence team.
• Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues.
• Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development.
• Expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance.
• Knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical chemistry and/or Microbiology techniques and instrumentation; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWise application).
• Strong analytical and problem solving abilities.
• Strong verbal and written communication skills.
• Expert knowledge and experience in Analytical Method Validation and Transfer.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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