Senior GMP Training Specialist II *PC 1492

Your Role: 

The role is responsible for supporting implementation and maintenance of the GMP Training program to ensure compliance with all relevant regulatory requirements. 

The role will develop and facilitate quality systems training, maintain training assignments and documentation, and drive human performance through continuous improvement initiatives.

Essential Duties and Responsibilities:

• Utilize instructional design principles to create a variety of blended training materials (e.g. OJT guides, computer-based modules, videos, presentations, job aids, etc.) - with a focus on training effectiveness and human performance.
• Collaborate with key stakeholders to perform needs analysis and implement appropriate training and development solutions to drive human performance.
• Author, revise, review and approve documents to support training project implementation (e.g. SOPs, work instructions, OJT documents, job aids, etc.).
• Conduct basic to advanced level trainings in a variety of modalities (instructor-led, virtual, OJT, etc.).
• Perform training administration tasks in the Learning Management System (LMS) (e.g. course creation and assignment, curriculum management, training verification).
• Track, trend and monitor training compliance; prepare and distribute site training metrics.
• Maintain and facilitate Quality Systems training courses (e.g. GDP, GMP, Doc Management System, etc.).
• Maintain training documentation in a compliant state.
• Proactively contribute to continuous improvement and development of the GMP Training program.
• Act as an SME to support training-related requests during inspections and audits.

Requirements:

• Bachelor's Degree in life science; Plus 5 five years’ experience developing and conducting training in a GxP regulated environment: or equivalent combination of education and experience.

Skills:

• Experience performing administrative tasks in a Learning Management System (LMS).
• Experience as a qualified trainer for on-the-job training (OJT).
• In-depth knowledge and full understanding of pharmaceutical GMPs (US and EU); Clear understanding of standards of practice used in the manufacture of biotechnology products.
• Advanced proficiency with training authoring tools such as Captivate, Articulate, Lectora, Camtasia, etc.
• Excellent verbal and written communication skills for broad audience, including senior management.
• Demonstrated ability to influence without authority, and lead large or technically complex, cross-functional projects with minimal direction.
• Experience effectively supporting FDA inspections, EU regulators and customer audits.
• Must have excellent verbal, written, interpersonal, organizational and communication skills.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch.  The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.  Must be able to travel routinely by car and plane.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment. This job requires the person to be mobile to visit company sites.  Due to the travel requirements, this position may be exposed to natural elements of nature.  

The anticipated base salary range has been established at $88,100 - $119,200/year. The hiring range for this position is expected to fall between $88,100 - $103,650/year, reflecting the range candidate