GMP Technical Training Manager Job in Boston North, Massachusetts Us
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medicine for more than 50 years, is dedicated to creating and providing pioneering medical imaging solutions to improve treatment of human disease. The companys proven success in discovering, developing and marketing innovative medical imaging agents provides a solid platform from which to bring forward breakthrough new tools for the diagnosis and management of disease. The company is home to leading cardiac imaging brands, including Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), DEFINITY Vial For (Perflutren Lipid Microsphere) Injectable Suspension, and TechneLite (Technetium Tc99m Generator). The company is also now home to ABLAVAR (gadofosveset trisodium), a first-in-class blood pool contrast agent for magnetic resonance angiography. Lantheus has more than 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.
In this position the ideal candidate will ensure all required employees, including contract labor, are trained on the impact of cGMPs on manufacture, testing and distribution of drug products. Responsibilities include:
Consult with organizational leadership and staff to assess training needs and provide guidance to ensure that GMP and job training practices are compliant with FDA and international Regulatory Health Authority requirements. Provide group and individual training sessions, including scheduling, training material/media development, presentation and record keeping.
In collaboration with management, develop targeted, technical training programs that ensure that all required employees, including contract labor, are trained about how cGMPs impact the manufacture, testing and distribution of drug products.
Design, develop and implement, with input from Subject Matter Experts, cGMP and Quality System training programs that align with strategic initiatives. Develop the content and format of training materials for GMP and technical training programs.
Maintain a high commitment to quality and compliance. Ensure appropriate personnel acquire necessary skills to perform their job effectively and efficiently.
Deliver energetic training programs that engage participants in acquiring designated job skills.
Maintain current expertise in all related external regulatory requirements, technology, and internal systems, processes and procedures.
Act as internal resource for site training/education needs. Create new and innovative ways of delivering GMP training.
Select GMP training topics and develop GMP training materials for the facility at least quarterly.
Develop GMP training materials for departments on as needed basis to address emerging trends or fulfill management requests for reinforcement of training on specific topics.
Manage and maintain computerized systems used for the purposes of training and documenting training records.
Develop and maintain training performance metrics and continuously evaluate the effectiveness of training programs.
Track status of compliance to training requirements and follow-up with management with presentation of monthly performance metrics.
Maintain company training record system and provide training to users.
The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards. Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
Requirements include a BS/BA degree in a scientific discipline with a minimum of 7-10 years of experience in a pharmaceutical industry or related GMP environment, or equivalent. Occasional travel based on business need. Non-routine scheduled work required on evenings, weekends.
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