Job Description
Job Summary:
- The purpose of this position is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process, and final products.
- In addition, will also develop and validate analytical methods.
Essential Duties & Responsibilities:
- Perform analytical testing in support of product development and method validation.
- Conduct laboratory tests in compliance with established internal Standard Test Methods (STMs), compendia’ and vendor/partner supplied methods.
- Maintain organized records of tests performed and results obtained by following company policies.
- Perform basic troubleshooting and preventative maintenance of laboratory equipment.
- Understand and comply with all company policies, safety procedures, and SOPS, including cGMPs and cGLPs.
- Assist in the preparation analytical data for internal and external meetings and presentations.
- Assist in performing laboratory investigations. Contribute to written investigation reports as required.
- Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
- Participate in the transfer of methods to/from the Quality Control department.
Supervisory Responsibilities:
- The incumbent works closely with all functional areas in Research and Development, Manufacturing, Quality Assurance, Quality Control, Document Control and Regulatory Affairs.
Skills
Education and Experience:
- Bachelor’s degree in relevant field of study (e.g. chemistry, pharmacy, biology, engineering, etc.) from an accredited college or university required. 1 year combined academic and pharmaceutical industry experience.
Knowledge, Skills, and Abilities:
- Basic understanding of the chemical and physical principles upon which formulation, process development and analytical methodology is based.
- Familiarity with concept of cGM Ps.
- Basic skills in using typical laboratory and processing equipment (e.g. HPLC, UV Spec, pH meter, centrifuge, etc.).
- Ability to utilize scientific information resources within the assigned area of responsibility.
- Good observation skill, problem solving, and troubleshooting skills (e.g. rational progression of investigation).
- Good understanding of the scientific thinking in the design of experimental protocols.
- Basic documentation skills (e.g. notebook, reports) with attention to detail and legible handwriting.
- Good organizational skills (e.g. daily tasks, documentation, archived information).
- Good interpersonal skills (e.g. working with members of other teams to achieve shared goals).
- Good verbal and written English communication skills (e.g. able to participate in scientific discussions and written interactions).
- Proficient in the use of computers and widely used workplace applications (e.g. Microsoft Office, Outlook, graphing software, etc.).
- Ability to be flexible in adapting work plan to current corporate goals.
- Basic time management skills (e.g. multitasking and task prioritization).
Required Skills:
- Time Management.
- Rational.
- Problem Solving.
- Microsoft Office.
- Sampling.
Additional Skills:
- Regulatory Affairs.
- Document Control.
- Method Validation.
- Pharmacy.
- Sops.
- Lockout tagout.
- Quality assurance.
- HPLC.
- CGM PS.
- Quality Control.
- Organizational Skills.
- Documentation.
- Laboratory.
- Maintenance.
- Analytical Testing.
- Equipment sales.
- Product development.
- Chemistry.
Languages:
- English language- Read, Write and Speak.