Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- Applies knowledge of site procedures (SOPs) and current Good Manufacturing Practices (GMPs) [e.g. ICH Q7]. Applies knowledge of GMP and GLP to daily activities.
- Conducts routine and non-routine analyses of raw materials, intermediates, and finished product samples.
- Performs cleaning verification analysis and visual inspection for manufacturing equipment.
- Reviews analytical data and results of testing to ensure accuracy and compliance to appropriate specifications and protocols.
- Assists in lab investigations as required.
- Participates in all group meetings and staff training sessions. May present data or prepare information for others to present.
- Suggests improvements to laboratory test methods, procedures when noted.
- Participates in weekly laboratory clean-up.
- Performs simple preventative maintenance and calibration of analytical instrumentation.
- Troubleshoots instrumentation and test methods.
- Writes and executes protocols and reports.
- Other duties as required.
Qualifications
Highest qualification: University
- Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, NMR, KF titration, DSC/TGA, PSD, etc.
- Working knowledge of software such as Empower, LIMS, LabX, electronic notebooks, MS Word, MS Excel.
- Excellent technical and laboratory skills to execute analyses efficiently and reliably in cGMP regulated analytical environments.
- Demonstrates effective time management skills and ability to work independently and as part of a team.
- Ability to work effectively with people from wide range of skill levels and experience.
- Strong verbal and written communication skills.
- High school diploma (or equivalent) and 3+ years of experience OR
- Associates (or equivalent) and 2+ years of experience OR
- Bachelor's degree (or equivalent)