Job Title: Quality Control Bioassay/Biochemistry Specialist
* Perform method validation, transfer and routine analysis to ensure compliance with quality standards.
* Conduct cell culture techniques, including cell banking, revival, and routine passaging of adherent and suspension lines, to support drug substance testing and release.
* Collaborate cross-functionally to execute the strategy and business planning processes, ensuring seamless integration with key stakeholders.
* Achieve a high level of competence in laboratory methods and procedures to support analytical testing and release.
* Ensure all tasks associated with routine operations of a QC Bioassay/Biochemistry laboratory are carried out safely and efficiently.
* Participate in QC risk assessments, including quality risk assessment and EHS risk assessment, to identify potential risks and develop mitigation strategies.
* Develop training materials for QC Bioassay/Biochemistry Laboratory personnel to enhance knowledge and skills.
* Act as trainer for analytical methods and procedures to build capability within the team.
* Manage lab scheduling and planning for routine testing, investigational testing, and projects, ensuring timely completion and delivery.
* Monitor laboratory KPIs, stock control of laboratory consumables and reagents, and support future expansion/upgrade projects.
* Participate in the laboratory deviation and investigation process, including OOS, OOT, and nonconformance, to implement CAPAs and change control.
* Prepare required GMP documents, such as SOPs, OJTs, protocols, methods, and reports, to maintain regulatory compliance.
* Provide effective communication and support project management regarding internal and external clients, such as Quality Assurance, Regulatory Affairs, and Analytical Development.
Required Skills and Qualifications:
* Strong understanding of quality standards and regulations.
* Excellent analytical and problem-solving skills.
* Effective communication and collaboration skills.
* Ability to work independently and as part of a team.
* Highly organized and detail-oriented.
Benefits:
* Competitive salary and benefits package.
* Opportunities for professional growth and development.
* Collaborative and dynamic work environment.
Others:
* Must be able to work in a fast-paced environment.
* Must be able to prioritize tasks effectively.
* Must be able to maintain confidentiality and handle sensitive information.