Chemical Analyst

The Analytical Chemist is responsible for developing analytical methodologies to ensure key cGMP, GLPs and company quality standards are being met throughout the production workflow. This will involve the identification and documentation of key analytical parameters, the identification of origins of impurities, and the identification of appropriate analytical strategies for measuring key parameters.

Develop robust and appropriate analytical methods to characterize and improve the production of hemp raw materials, intermediates, and APIs.
Develop and implement procedures according to ISO 17025 standards.
Prepare and review SOPs, test methods, scientific reports and other GMP/GLP regulatory documentation.
Execute sample analysis for clients using HPLC, ICP-MS, GCMS, LC-QQQ instruments.
Work with team members to develop and implement robust process monitoring for the production of raw hemp materials, intermediates, and APIs.
Interpret raw data, organize results, generate and review reports, and communicate findings to teams.
Develop and maintain the Laboratory Information System (LIS) by identifying needed inputs, outputs, and identifying potential problems. Recommend improvements, establish priorities, write user manuals.
Ensure analytical analysis is performed in a timely manner.
Comply with all safety requirements, laboratory SOPs, and company policies and procedures.
Maintain laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair.
Lead all necessary regulatory reporting.
Assist in hiring and development of new employees.
Assist with ISO renewal.
Assist with inventory management for analytical lab.
Manage storage, security, and disposal of customer and company material samples

Quality/Regulatory Responsibilities

Demonstrate technical proficiency and self-assuredness in applying cGMP and GLP standards.
Apply cGMP concepts in association with department specific responsibilities.
Ensure all documentation produced complies with cGMP and GLP standards.
Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
Ensure work complies with all state and federal regulations, including but not limited to GMP, GLP, DEA, FDA, etc.

Qualifications

MS in Analytical or Organic Chemistry is preferred with minimum of 4 years experience in a GMP environment.
BS in Chemistry or equivalent with a minimum of 8 years experience in a GMP environment is required.
Minimum of 3 years experience in chromatographic method development
Proficient with HPLC-(UV), GC-MS, ICP-MS,LC-MS
Experience with Process Development of APIs (Active Pharmaceutical Ingredient)
Demonstrate experience in writing method validation protocols and reports
Prior experience in cannabis extraction preferred
Proficient in Microsoft Office Suite.

Interested applicants should email resumes to: jared.gregor@adeccona.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

  • Apply with Adecco

Reference number US_EN_2_226875_140919