Chemical Compliance Manager job – PAN AMERICAN GRAIN Company – Arecibo, PR

Chemical Compliance Manager

PAN AMERICAN GRAIN Company

Arecibo, PR

Pan American Grain is seeking for a Chemical Compliance Manager to facilitate and manage the development of methodologies and data analysis to support the optimization of product cultivation and processing. The ideal candidate will possess the knowledge and experience of method development using GCFID and HPLC instruments, which includes but not limited to: calibration, builds, knowledge of QC/QA procedures, pipetting techniques, data analysis/reporting, and laboratory management. This position effectively performs activities as directed to ensure quality and compliance with applicable regulatory requirements relating to controlled substances and FDA drug submissions.

Essencial Dutties and Resposibilities:

  • Implement strategic structure for quality assessment/regulation (ie. FDA).
  • Forward looking skills in determining a battery of tests that will be required to support a product development program.
  • Ability to develop new methods as well as perform routine assays in a more controlled environment.
  • Meticulous lab skills and record keeping and excellent attention to details.
  • Gas Chromatography method optimization and development.
  • Solvent serial dilutions and laboratory consumables management and inventory.
  • Laboratory instrument management.
  • Manage and enforce compliance procedure to operate a cGMP manufacturing facility to meet DEA regulation to prevent material diversion.
  • Conduct and/or support internal audits, client audits, and regulatory audits including, but not limited to: audit scheduling, preparation, execution, response/resolution and follow up.
  • Assist with the completion of all DEA reports including ARCOS reports and audits as required.
  • Provide project team presentation and direction in managing information from/to other departments (including Product Development, Manufacturing, and Quality) regarding regulatory submissions to government agencies. this may include the preparation of outlines, summaries, status reports, graph, charts, tables and slides for distribution and communication to other departments.

Qualifications:

  • BA in Sciences (preferably Biological Sciences, Organic Chemistry or Pharmacology)
  • 5 yrs experience in audited/regulated laboratory environment
  • Knowledge of Federal DEA and State of MO regulations involving controlled substances and Listed Chemicals.
  • Knowledge of pharmaceutical manufacturing practices, validation methods, inspection and testing methodologies.
  • Strong Organizational Skills with high attention to details.
  • Proficient with Microsoft Office (Word, Excel, Access, Outlook)
  • Strong writing and editing skills
  • Experience working with regulatory agencies and trade associations.
  • Fully Bilingual: English ans Spanish.

EE/MALE/FEMALE/VETERANS/DISABLED

Job Type: Full-time

Required education:

Required experience:

  • AUDITED/REGULATED Laboratory Enviroment: 5 years

Required language:

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