Quality Assurance Training Specialist II

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

At Millipore Sigma, as the Quality Assurance Training Specialist 2 at our St. Louis Cherokee CDMO facility, you will be expected to design, develop, facilitate and lead site/staff training programs and initiatives while fostering a collaborative learning culture. You will implement and direct the site training program and oversee training performance and compliance across all site departments. You will be responsible for management of the site training program, including management of the training curriculums and continuous improvement of the training systems to ensure they remain consistent with current expectations for cGMP training programs.

This position requires knowledge and understanding of cGMP guidelines as they pertain to training requirements within the API pharmaceutical manufacturing industry, including quality regulations, training development and delivery, and change management.

The ideal candidate will have a passion for success enabled through training and development of employees through administration of programs that will improve skills and knowledge. The candidate will showcase initiative in identifying and implementing improvement projects to influence change in training programs and strengthen system compliance.

This position will be responsible for:

• Definition, implementation, and oversight of the site training program for all departments, including the process and requirements for training curriculums and learning items.
• Leading the cross-functional site Training Review Board to ensure proactive discussion and alignment of site training requirements across all site roles.
• Development, maintenance, and organization of training curriculums and learning materials for site wide programs, including but not limited to, New Employee Onboarding, cGMP/GDP, and Data Integrity, and Train the Trainer.
• Delivery of classroom and on-the-job training associated with quality events and/or cGMP requirements.
• Management of training requirements, assignments, and completions in the electronic Learning Management System (LMS)
• Writing and revising QA operating procedures, work instructions, forms, and job aids related to the training program with minimal supervision
• Creation and tracking of key performance indicators demonstrating successful training compliance.
• Act as Subject Matter Expert for the site training program in internal, customer, and regulatory audits.
• Travel-up to 5%

Who You Are

Minimum Qualifications:

• Bachelor's degree in any discipline
• 5+ years' experience working in a quality role within a cGMP regulated pharmaceutical environment
• 2+ years' experience in a training role or function

Preferred Qualifications:

• Strong working knowledge of cGMP and regulatory standards as they pertain to Quality Systems and Training
• Independent, self-starter with proven results in training environment
• Experience working with Training systems to track and evaluate compliance management and program effectiveness.
• Strong interpersonal and communication skills.
• Ability to lead discussions and instruct participants in training classes using a variety of instructional techniques.
• Strong teaching and facilitation skills.
• Ability to work and communicate well with other key groups to achieve improvement and operational results.
• Demonstrated knowledge and experience in various computer skills, including Windows, Word for Windows, Excel, and Outlook, as well as familiarity working in a window-based environment.
• Demonstrated experience in detailed review work…