MAIN PURPOSE OF ROLE
Summarize the main purpose of the role.
To provide analytical support to the manufacturing plant in the areas of analytical testing and review, release of incoming chemicals and in process solutions, procedure writing and review, analysis of analytical data through software programs, investigation and resolution of out of specification issues.
**MAIN RESPONSIBILITIES**:
Create and maintain a respectful work environment by listening, seeking facts to support decisions, managing one's own reactions, and addressing unacceptable behavior
Conduct laboratory experiments and testing of raw materials-Support evaluation and upgrade of laboratory procedures.
Maintain working knowledge and understanding of USP, FDA, ISO, and any other regulatory standards applicable to chemical testing and validation
Promote safety and ensure a safe work environment and safe work habits.
Use and maintain highly advanced scientific instrumentation in the Analytical Laboratory (e. g. high pressure liquid chromatographer, ion chromatographer, Fourier transform infrared spectroscopy).
Provide support to the manufacturingsite in the areas of analytical testing and review.
Communicate with and listen to lab staff on a daily basis regarding work team performance, strategic initiatives, policy changes, safety, quality, etc.
Coordinate and manage external vendor equipment qualifications including provision of necessary protocols, reports and approval.
Design and supervise laboratory experiments, testing of materials.
Develop and maintain procedures in compliance with external/internal audits.
Ensure adherence to all applicable ISO, FDA quality regulations and industry standards.
Ensure correct documentation on Analytical Laboratory testing.
Maintain all required laboratory records
Ensure training materials are updated accordingly and appropriate personnel are trained.
Quealifications
- Bachelor's Degree Chemistry, Chemical Engineering, Materials, Pharmacy, Physics, Metallurgical Science or related field.
- At least 1 year of experience or relevant educational practice
- Ability to follow instructions and maintain safety in the work place
- Knowledge of Good Laboratory Practices (GLPs) and use of basic lab equipment meter, analytical balance, HPLC, among others.
- Working knowledge of quality systems and analytical test methods.
- Proficiency in the use of industry standards such as USP, AAMI, ACS, EN, ISO, GMP and GLP.
Language Proficiency
- Intermediate Commands of English / Required