QC Senior Scientist (Raw Materials)
Мэтч & Сопровод
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Описание вакансии
TL;DR
QC Senior Scientist (Raw Materials) (GMP analytical testing): Supporting the testing and release of raw materials used to manufacture life-changing therapies with an accent on method transfers, validations, investigations, and data integrity. Focus on leading technical laboratory activities, troubleshooting quality events, implementing corrective actions, and improving compliance in a fast-paced GMP environment.
Location: On-site in Portsmouth, New Hampshire, United States; regular Monday–Friday office hours.
Company
is a global life-sciences manufacturing organization supporting the development and production of medicines and therapies.
What you will do
- Perform laboratory testing for routine quality control, method transfers, validations, and investigations.
- Author and review technical documents, protocols, reports, and analytical methods.
- Transfer and implement analytical methods, and verify laboratory equipment, electronic templates, and testing systems.
- Review analytical data for GMP and data integrity compliance, investigate laboratory events, and support corrective actions.
- Collaborate with Quality, MSAT, Logistics, and other cross-functional partners on projects, audits, and technical transfers.
- Train and mentor colleagues, act as a raw-material compliance subject matter expert, and drive continuous improvement.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline.
- Knowledge of analytical testing, method transfers, and method validation principles.
- Experience in a GMP-regulated laboratory, pharmaceutical, biotechnology, or related environment.
- Strong technical writing, documentation, data review, troubleshooting, and organizational skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Ability to work on-site in Portsmouth, New Hampshire during regular Monday–Friday office hours.
Nice to have
- Advanced degree such as an MS or PhD.
- Experience with pharmaceutical compendia.
- Experience with LIMS, TrackWise, DMS, or electronic laboratory notebooks.
Culture & Benefits
- Agile career development and opportunities to grow.
- Inclusive, ethical, collaborative, and team-focused work environment.
- Medical, dental, and vision insurance.
- Performance-recognition compensation programs.
- Opportunity to contribute to the delivery of life-changing therapies.
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