Thermo Fisher Scientific QC Assay Validation Scientist 1 in Plainville, Massachusetts
Lead 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. Additional responsibilities will include driving continuous improvement/Operational Excellence/innovative implementations; represent QC (method, validation, transfer) on cross functional teams; and providing guidance/training/coaching to junior colleagues; troubleshooting. May lead client and technical projects by self or in a team as assigned by management.
Has SME knowledge of varied aspects or a specialized aspect of a discipline.
Able to holistically review and authorize all laboratory data, and have an extensive overall knowledge of all laboratory operations. Able to 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. Able to build or enhance understanding of scientific discipline; supports training of staff; mentoring and coaching junior colleagues. Displays 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. Expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance. Solving highly complex mathematical problems and situation dependent problems using convoluted information. 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.
Demonstrated experience in Quality Control. Reasoning ability including strong analytical and problem solving abilities. Strong verbal and written communication skills. Expert knowledge and experience in Analytical Method Validation and Transfer. experienced and proficient with 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. Experience leading Change Control and Risk Assessments.
Individual should have thorough 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); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments, Plans PPI initiatives
Leads project with minimal supervision, manage project timelines and deliverables. Established 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. Coordinates action plans and contribute to executing toward team/project goals
Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development. Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
Delivery on high business impact projects/activities/changes.
Interacts with clients, presents data to clients as group representative, independently on occasion and with minimal supervision.
Decisions frequently impact whole work group/ project team.
3-5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field. 2-4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field. 1-3 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph.D. in Science/related field
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.
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