Chemist II
Chemist II
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Overview
Element has a current opening for a Chemist II to join our growing team in Ann Arbor MI. Were looking for a detail-driven and proactive Chemist II to join our fast-paced collaborative team supporting both Research & Development (R&D) and Current Good Manufacturing Practice (CGMP) projects. This role demands a thorough understanding of regulatory frameworks with an unwavering commitment to impeccable GMP documentation and compliance. The ideal candidate will confidently manage multiple projects independently deliver consistent high-quality results on schedule and contribute meaningfully to routine testing and continuous process improvements.
Responsibilities
- Execute chemical analyses and testing to support R&D and CGMP projects ensuring full compliance with regulatory standards using a wide range of advanced analytical techniques.
- Maintain meticulous GMP documentation that meets all regulatory and quality assurance requirements.
- Independently oversee assigned projects from initiation through completion delivering timely results without compromising quality.
- Lead root cause investigations for deviations and Out of Specification (OOS) results and implement effective corrective and preventive actions.
- Collaborate cross-functionally to drive problem-solving optimize processes and enhance overall quality.
- Support routine testing to consistently meet production and quality assurance goals.
Skills / Qualifications
- Bachelors degree in chemistry or related scientific discipline; advanced degree preferred.
- 35 years of experience in CRO CDMO or pharmaceutical settings with regulated environments.
- Proven expertise within CGMP frameworks and regulatory compliance.
- Proficient with diverse analytical instrumentation including HPLC GC-FID ICP-MS FTIR LC-MS UV-Vis dissolution apparatus and microplate readers.
- Demonstrated excellence in GMP documentation and compliance adherence.
- Strong analytical mindset with hands-on experience conducting root cause analyses for deviations and OOS events.
- Effective multitasking and project management skills with the ability to prioritize in a fast-paced environment.
- Excellent communication and teamwork skills fostering a collaborative work atmosphere.
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Diversity Statement
At Element we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming the worlds most trusted testing partner.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age disability ethnic origin gender marital status race religion responsibility of dependents sexual orientation or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
Employment Type
Unclear
