Under general supervision, provide technical expertise and perform a variety or technical duties in the laboratory.
This position falls under the Research and Development structure which reports to the Director of Research and Development.
Major Functions Objectives:
- Assists supervisor to plan activities concern with development, application and maintenance of quality and analytical standards for processing materials into partially finished or finished material or product:
- Develops and initiates methods and procedures for inspection, testing and evaluation.
- Devises sampling procedure, designs forms for recording, evaluating and reporting quality and reliable data and writes instructions on use of forms.
- Establishes program to evaluate precision and accuracy of production and processing equipment and testing, measurement and analytical facilities. Including but not limited to, qualification and calibration program for laboratory equipment.
- Develops and implements methods and procedures for dispositions and devises methods to assess cost and responsibility of discrepant material.
- Compiles and writes training material and conducts training sessions on quality control and analytical activities.
- May assist in any of the following areas of quality-control engineering as design, incoming material, process control, product evaluation, inventory control, product reliability research and development and administrative application.
- Performs other duties as assigned.
Special Knowledge, skill and ability requirements:
- Working knowledge of a variety of laboratory analytical techniques and instruments including many of the following: UV/VIS spectrometer, FTIR, HPLC, GC, pH meter, auto titrators, analytical balances, polarimeter,dissolution tester.
- Computer skills of operation of laboratory equipment and for data process/storage.
- Maintains advanced knowledge of these techniques and instruments including training and troubleshooting capabilities.
- Has ability to understand and follow written methodologies in accordance with cGMP/cGLP standards.
- Understands and applies USP general chapters.
Education or Equivalent Experience:
- Advance degree in Analytical Chemistry or BS in related field with at least 2 years experiences in an analytical lab.
Management & Organizational Challenges:
- Quality mindset with a focus of strong consistent practices in cGMP.
- Patnering, communicating and working with other departments.
Environment / Culture:
- Fast-paced, very dynamic environment with expectation of multi-tasking and accomplishing tasks in a timely manner.
- Constant communication with other departments.
- Self-Driven by continuous improvement
- Detailed oriented.