Chemist

This role is responsible to support the development and transfer of analytical methods. Additionally responsible for independently writing, reviewing, executing and approving protocols, verifications, and method transfers. Has an intermediate level of expertise in analytical chemistry, chromatographic methods of analysis and instrumentation to support peers and senior level personnel. This individual will have a basic understanding of current Good Manufacturing Practices (cGMP) to perform these duties.

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, address high priority requests, problem solve and move productively. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.

Responsibilities

• Support the development and transfer of analytical methods
• Independently write, review, execute and approve protocols, verifications and method transfers
• Articulate work related issues clearly and effectively to management and peers
• Perform accurate chemical testing utilizing instrumental methods of analysis (HPLC, GC, FRIT, UV-VIS, pH, Moisture, etc.) with emphasis on chromatography
• Update and route SOPs, MOAs, Specifications as delegated by manager
• Provide technical support for method validation, verification, transfers, and evaluations
• Perform troubleshooting of instrumentation by applying problem solving skills
• Maintain accurate records of all work performed related to given projects. Document testing in compliance with Good Documentation Practices
• Manages work and time based on departmental priorities
• Perform peer review of data to ensure compliance and accuracy
• Assist in the development of new product and process which meets industry requirements
  
  

Requirements

• Bachelor's Degree in Chemistry or Chemical Engineering, or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering)
• Minimum 1-3 years of laboratory experience in pharmaceutical quality assurance or other highly regulated industry.
• Working knowledge of cGMP practices including Good Documentation Practices
• Familiarity with laboratory techniques (GCMS, FTIR, NMR, HPLC, etc.)
• Requires advanced critical thinking and technical writing skills.
• Good organizational, communication, and interpersonal skills are necessary
  
  

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