Job Description
The ideal candidate will have a strong background in analytical laboratory operations and quality management systems, with knowledge of Good Documentation Practices and Data Integrity principles. They should be highly organized, detail-oriented, and accuracy-focused with the ability to work independently as a self-starter.
Duties and Responsibilities
* Ensure quality, compliance, and efficiency in team operations while aligning with site strategies.
* Act as the primary contact to address and manage laboratory issues related to equipment, analysis, compliance, and operational challenges.
* Plan and coordinate lab activities, ensuring timely release of materials and products, proper inventory management, and adherence to site lead times.
* Create capacity plans to meet business objectives, optimize laboratory performance, and proactively ensure team compliance with HSE and operational procedures.
* Oversee analytical activities, including data review, batch release, analytical method lifecycle (validation, transfer, troubleshooting), and stability studies in collaboration with the Analytical Development Team.
* Maintain inspection readiness, supervise compliance with cGxP, Good Laboratory Practices (GLPs), ALCOA+ principles, and manage deviations, CAPAs, and Change Controls as required.
* Lead and develop team members by monitoring training compliance, ensuring qualifications for GMP tasks, fostering a culture of engagement and accountability, and supporting talent development.
Key Skills and Qualifications
* Master's degree (preferred) or equivalent in Pharmacy, Chemistry, or a similar scientific field.
* 5+ years of experience in a similar role within a GMP-regulated laboratory environment.
* Strong familiarity with GMP compliance and laboratory workflows.
* Excellent written and verbal communication skills, including experience interacting professionally with external vendors or business partners.
Why This Role?
This is an exceptional opportunity to join our organization and contribute to the success of our team. The successful candidate will be responsible for leading a team of professionals in a dynamic and fast-paced environment.