Your role: The cGMP Manufacturing Training Specialist 2 at our Cherokee site/3300 S. Second Ave, St Louis, will be expected to design, develop, facilitate and lead staff training programs and initiatives while fostering a collaborative learning culture. You will oversee the training performance and compliance within operations. You will be responsible for maintenance of the training curriculums within GMP Operations, in addition to continuous improvement of the training systems to ensure they remain consistent with current expectations for manufacturing staff. This position requires technical knowledge pertaining to GMP Manufacturing and associated quality regulations, training development and delivery, change management, and strong analytical skills.
The cGMP Manufacturing Training Specialist 2 position is a key role within our GMP Operations Systems & Support team. Expectations of the GMP Operations System & Support team is to ensure "Compliance "and "Readiness" within our GMP Manufacturing teams, ultimately enabling high manufacturing success. Job duties include:
- Shift: Monday - Friday, 8:00am - 5:00pm
- 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
- The role may require occasional light lifting, up to 25lbs with assistance as necessary, and the ability to bend and twist/turn the body when performing tasks
- Role estimated to be 50% system management / project driven, 50% hands on training facilitator.
Who You Are:Minimum Qualifications:- Bachelor's Degree in Chemistry, Biology or any scientific discipline
- 2+ years of experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT)
- 2+ years of experience in a training role
OR- High school diploma or GED
- 5+ years of experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT)
- 3+ years of experience in a training role
Preferred Qualifications:- 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.)
RSREMD
Pay Range for this position: $79,100.00 - $118,700.00
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click
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