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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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Internet Publishing
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