Drive critical quality assurance from a remote setting as our next HPLC Analyst. This role is central to maintaining the integrity of our analytical data and ensuring compliance with the highest industry standards, directly impacting our product quality and regulatory standing.
Responsibilities
Execute quantitative and qualitative HPLC analysis on raw materials, in-process, and finished products.
Accurately interpret and report analytical results, maintaining detailed documentation and audit trails.
Ensure all analytical activities comply with current GMP, GLP, and internal SOPs.
Perform routine calibration, troubleshooting, and preventative maintenance on HPLC instrumentation.
Identify and investigate OOS/OOT results, implementing corrective actions as required.
Contribute to the continuous improvement of laboratory processes and analytical methodologies.
Requirements
2-5 years of hands-on experience as an HPLC Analyst in a regulated environment.
Demonstrated proficiency in GMP and GLP principles and their practical application.
Thorough understanding and proven experience with US FDA regulations, specifically 21 CFR Part 11.
Documented expertise in HPLC instrument calibration, maintenance, and basic troubleshooting.
Strong analytical problem-solving skills and attention to detail.
Ability to manage workload independently and collaborate effectively in a remote team setting.
Bachelor's degree in Chemistry, Biochemistry, Analytical Science, or a related field.
Nice-to-Haves
Experience with specific chromatography data systems (e.g., Empower, Chromeleon).
Familiarity with method development and validation activities.
Prior experience working in a fully remote analytical role.
What We Offer
Competitive salary and comprehensive benefits package.
A fully remote work environment, providing flexibility and work-life balance.
Opportunity to make a significant impact on product quality and regulatory compliance.
Investment in your professional growth and continuous learning.
A collaborative culture focused on innovation and scientific excellence.