Quality Control Lead Analyst: Biochemistry and Cell Biology
A challenging opportunity has arisen for a Quality Control Lead Analyst in the biotechnology and pharmaceutical industry. This individual will be responsible for leading quality control testing related to biochemistry and cell biology.
The key objectives of this role are:
• Develop and coach the Quality Control team and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Perform a variety of routine biochemistry and cell biology analytical testing techniques and associated documentation; including but not limited to ELISA, PCR, Bioassays, Cell Culture, water and cleaning validation sample testing and compendial methods in compliance with GMP requirements.
• Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Consistently deliver on specific area Key Performance Indicators.
• Operate to the highest standards of Safety, Quality, and Compliance.
• Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
• Provide coaching for the team members as part of the continuous improvement mindset.
• Role model the behaviours that creates a culture of dignity and respect.
• Responsible for being a designee for the people lead as required
• Lead projects as required
To excel in this role, you will need to possess:
• A degree qualification in Science/Quality/Technical disciplines.
• Minimum 4 years' experience in the biotechnology and/or pharmaceutical industry (preferably both).
• Leadership skills and experience managing daily activities.
• Preferably Lean Six Sigma experience.
• Excellent written and oral communication skills.
• Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Ability to work on their own initiative in a constructive manner, as well as working as part of a team.
• Excellent time management and organisational skills.
• Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
• Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
• Experience with continuous quality/process improvement tools (e.g. DMAIC, Lean QA, 5S etc).
• Excellent trouble shooting and problem solving skills.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.
• Ability to challenge the status quo with a continuous improvement mindset.
• Promoting a culture where diversity and inclusion is part of the DNA