Essential Functions

• Perform routine laboratory procedures including analyzing and reviewing data
• Receive and test samples
• Receive, prepare, test, release materials used for QC testing (for example: media, standards)
• Document laboratory work consistent with GxP requirements
• Maintain laboratory records and inventory for supplies and reagents
• Perform preventative maintenance on laboratory equipment in accordance with established procedures.
• Perform detailed technical and data integrity review of QC data as required
• Adhere to all effective TMDs/SOPs and safety requirements and document laboratory work consistent with cGMP requirements
• Initiate investigation reports attaching required documentation
• Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures
• Prepare and Autoclave supplies and garbage
• Model the organizational core values through day-to-day actions

EDUCATION, EXPERIENCE & SKILLS:

• Bachelors Degree in a scientific discipline
• Under two years experience in a pharmaceutical cGMP environment
• Basic knowledge of Microsoft Office - Word, Excel
• Basic knowledge of pharmaceutical GLPs and GMPs
• Knowledge of laboratory techniques and safety precautions
• WHMIS and biohazard safety awareness
• Ability to work in a fast paced and highly regulated environment
• Able to multi-task and adapt to changing priorities
• Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records
• Able to communicate and articulate information in both written and verbal forms
• Strong organizational and interpersonal skills; can work collaboratively with others.
• Able to interpret analytical data