What are the responsibilities and job description for the QC Laboratory Manager position at Organogenesis?
About Us
We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength.
Learn more about Careers at Organogenesis
What You Will Achieve:
This position is responsible for providing leadership, supervision and delivery of compliant laboratory system and data in support of Organogenesis products, and in accordance with appropriate regulatory, corporate and scientific guidelines. The position manages the QC operations for Incoming Raw Materials, Analytical, and Microbiology. In addition, this position provides oversight of studies in support of method validation, cleaning validation, process validation, and characterization activities.
How You Will Achieve It:
- Preparing and setting up the QC laboratories to operational readiness.
- Reviews and approves testing results/documentation generated by the laboratory or is responsible and accountable for delegating this review appropriately to associates. Ensures all operations are performed with 100% compliance to cGMP/ISO documentation standards.
- Managing the QC team in planning, organizing, performing, evaluating, reporting, storing, and accessing results and device history records for incoming raw materials, intermediates, components, and finished goods, ensuring maximum testing efficiency and optimum utilization of resources.
- Provide impact of procedural deviations and Out of Specification/Aberrant laboratory incidents, including providing recommendations and implementing corrective/preventative actions. Promptly conducts investigations of unexpected test results to meet testing deadlines.
- Establishes training requirements: develops, administers, and monitors the training program, maintains records in compliance with corporate and industry standards, and ensures a safe work environment.
- Manage new and ongoing development projects
- Writes and updates test procedures and systems to ensure continuous improvement in the quality of results and efficient use of resources. Evaluates validated analytical methods and procedures to optimize laboratory testing cycle time.
- Manage one or more direct reports
- Appraises the quality and quantity of work performed by associates and coaches them to improved performance through the Performance Appraisal and Career Development programs.
