Responsible for carrying out finished goods and raw material testing within an ISO accredited laboratory environment. Essential functions include tissues culture testing, virology and microbiological analysis.
Successful performance of job duties contributes to meeting testing schedules, customer satisfaction, departmental safety and quality objectives.
• Perform Raw material and Finished goods release testing according to standard operating procedures in a timely and efficient manner. Key tasks include:
Cell culture work handling a variety of different cell lines
Managing cell stock levels
Producing master and working cell banks as required
Perform finished goods testing according to standard operating procedure using a
variety of cell culture techniques.
Microbiological sampling and finished goods testing including endotoxin testing and
Environmental monitoring of laboratory areas and manufacturing areas
Calibration/daily checks of laboratory equipment
• Provide support to initiate and implement Validation processes, technical investigations and improvement initiatives.
• Contribute to the preparation of written reports as and when required.
- May be reuqired to perform other duties as and when required.
• Maintain thorough and complete product test records per in-house testing procedures and in accordance with ISO 13485 standards.
• Participate in personal development opportunities to further enhance skills and knowledge relevant to the position
• Support and maintain Company's Safety, Environmental and Waste Management programme.
Requires a bachelor’s degree within biological and/or chemistry science
• 1-2 years experience in a biotechnology or similar environment desired.
• Experience working within a regulated laboratory environment.
• Good aseptic techniques required
• Strong organizational skills and a commitment to excellence
• Ability to prioritise assignments
• Able to work independently as well as work within a diverse team
• Familiar with MS Office products
• Excellent oral and written communication skills
Has high level of contact with all departments primarily Quality Assurance and technical departments
Works in a laboratory environment. Must be able to work safely with chemicals and hazardous materials. Will be expected to perform some manual handling. Must be able to work overtime and flexible shifts where required.
*LI - KP1