GMP Training Specialist 2

Merck•Saint Louis, MO

3d•Onsite

About The Position

The cGMP Manufacturing Training Specialist 2 at the Cherokee site in St. Louis is responsible for designing, developing, facilitating, and leading staff training programs and initiatives to foster a collaborative learning culture. This role oversees training performance and compliance within operations, maintaining training curriculums and continuously improving training systems to align with current manufacturing staff expectations. The position requires technical knowledge of GMP Manufacturing, associated quality regulations, training development and delivery, change management, and strong analytical skills. As a key role within the GMP Operations Systems & Support team, the focus is on ensuring compliance and readiness within GMP Manufacturing teams to enable high manufacturing success.

Requirements

Bachelor’s Degree in Chemistry, Biology or any scientific discipline AND 2+ years of experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT) AND 2+ years of experience in a training role
OR High school diploma or GED AND 5+ years of experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT) AND 3+ years of experience in a training role

Nice To Haves

Experience working with Training systems to track and evaluate compliance management and program effectiveness.
Strong interpersonal and communication skills and the ability to work effectively within a team environment.
Strong knowledge of GMP API manufacturing.
Detailed oriented with a future oriented mindset.
Highly motivated self-starter who takes initiative and thinks creatively to develop innovative solutions.
Strong training and facilitation expertise, including designing, delivering, evaluating, and continuously improving training programs, curricula, and methodologies while fostering discussion, consensus, and positive change.
Proficiency with ManGo, TrackWise, and SAP systems, along with demonstrated process improvement experience and familiarity with FDA, EMA, and other applicable regulatory standards.
Prior training experience in an API manufacturing environment.
Demonstrated knowledge and experience in various computer skills, including Windows (Word, Excel, PowerPoint, etc.).

Responsibilities

Train staff on GMP/GDP standards, safety and quality best practices, API and intermediate production techniques, and proper operation of manufacturing equipment and records.
Led comprehensive onboarding and delivered group and individual training for new Operations staff across a range of technical and operational areas.
Partner with Operations managers to design, execute, and administratively manage comprehensive training programs—including custom instructional materials and visual aids—aligned with core organizational goals.
Design robust GMP training programs by conducting targeted needs assessments across individuals, teams, and operations, leveraging post-training evaluation data to continuously refine instructional methods and learning objectives.
Create and track key performance indicators demonstrating successful training compliance.
Identify and implement improvement projects that improve skillset of senior employees and subject matter experts.
Lead Train the Trainer initiatives to expand training knowledge and ability of senior staff and subject matter experts.
Serve as an Operations Training subject matter expert during customer audits and regulatory inspections.
Work effectively cross-functionally by interacting daily with colleagues across the site.
Complete/assist with deviations and CAPAs related to training program.