Analytical Chemist II

1/6/23

Tampa, FL

1893

Analytical Chemist II

PRIMARY PURPOSE:

Responsible for the design, development, qualification, validation, and implementation of analytical procedures in support of research, GMP production, and stability testing. Must have extensive cGMP experience and FDA and ICH Guidance experience. Must be able to provide leadership and mentoring to Chemist I, Chemist II and Chemist III. Must have thorough understanding of Good Laboratory Practices, Good Documentation Practices, Method Development and Method Validation. Must have experience in preparing validation protocols and writing summary reports. Must have experience in writing Standard Operating Procedures.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Develops efficient and selective analytical procedures (with emphasis on HPLC, GC, TOC and Atomic Absorption) for assigned projects
  • Prepares qualification and validation protocols and reports for analytical procedures and instrumentation
  • Performs sample analysis and reviews data packages
  • Accurately records raw data and analyzes, as well as calculates and interprets the results. Ensures all documentation produced is in compliance with cGMP standards.
  • Prepares high quality written documentations (notebooks, SOPs, and analytical procedures) and assists with regulatory documentation
  • Troubleshoots analytical instrumentation
  • Communicates effectively in verbal and written form on research results and plans
  • Volunteers to assist with task not directly related to a specific project
  • Demonstrates initiative in handling responsibilities
  • Contributes to the technical growth of the department and company
  • Attends project meetings and prepares project updates
  • Participates in self-development activities
  • Maintain analytical reagents in laboratory including but not limited to: inventory, current SDS, PPE required for handling, waste generation and disposal.
  • Assist Validation teams in cleaning validation activities.
  • Promote GMP and safety throughout the facility.
  • Promote continuous improvement and customer satisfaction.
  • Recognize OOS or out of trend results and under the direction of the Supervisor assist in the completion of lab investigations
  • Potential exists for exposure to potentially harmful chemicals. Be responsible and accountable for compliance with all aspects of the company's Health and Safety policies, and Safe Work Procedures
  • Participate in other activities as assigned by the Lab Manager or QC Director

QUALIFICATIONS:

Required

  • Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
  • Working knowledge of FDA regulation for drug/device especially for the lab.
  • Ability to use a personal computer and peripheral equipment to accurately enter an analyze data and produce reports.
  • Knowledge of chemical safety and protective equipment.
  • Knowledge of various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectrum, HPLC, GC, atomic absorption.
  • Knowledge of cleaning method validation.
  • Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
  • Ability to handle and resolve recurring problems.
  • Communicates effectively in verbal and written form on research results and plans
  • Contributes to the technical growth of the department and company
  • Ability to work in a dynamic fast paced environment-sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
  • Must be able to lift up to 15 pounds.

EDUCATION AND TRAINING:

  • Bachelor’s degree in Chemistry or appropriate discipline with 5-7 years related experience in a pharmaceutical industry
  • MS in Analytical Chemistry or equivalent with 3-5 years related experience in a pharmaceutical industry.
  • Familiarity with the use of MS Word, MS Excel, MS Access Knowledge and application of applied mathematics
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