Position Overview:
The Quality Control Technician plays a crucial role in ensuring the quality and compliance of our production processes. This position involves conducting Work in Process (WIP) testing for antigens, final batch release testing, stability testing, environmental and utility testing, and participating in qualification/validation activities. The QC Technician will employ various techniques such as microbiology, cell culture, and molecular biology to perform tests, adhering to approved Outlines of Production and Good Manufacturing Practices (GMP).
Responsibilities:
Execute WIP and Final Product batch release tests following approved Outlines of Production and GMP principles.
Utilize various techniques, including microbiology, cell culture, and molecular biology, to perform testing.
Conduct Environmental Monitoring (EM) tests and utilities testing across all departments.
Perform stability testing to assess product shelf life.
Collaborate in validation activities, including equipment and method validations.
Update, maintain, and create Standard Operating Procedures (SOPs), Standard Outlines (SOs), Master Data Forms (MDFs), and forms.
Identify and report Out of Specification (OOS) or deviations to the QC Manager.
Initiate and complete investigations when required.
Communicate results to production departments and collaborate on continuous improvement initiatives.
Occasionally work evenings, weekends, and participate in an on-call schedule.
Ensure adherence to all Quality systems.
Contribute to cleaning duties to maintain a clean and organized work environment.
Manage reagent inventory and conduct expiry checks on materials.
Perform other duties as required.
Minimum Qualifications:
Bachelor of Science or Technical Diploma in Biotechnology or Laboratory Technology.
Minimum of 2 years of laboratory experience with GMP training.
Advanced analytical and time management skills.
Excellent problem-solving skills.
Strong communication and decision-making skills.