Training Specialist
3 weeks ago
The opportunity
The Training Specialist is responsible to provide oversight of QC laboratory training program, including new hire and cross-training programs. Partner with Training Manager and departmental Subject Matter Experts (SMEs) to develop, facilitate and evaluate training programs for QC Laboratory, related to GMPs (Good Manufacturing Practices), lab procedures and processes, lab equipment, CAPA and/or other training initiatives. Other activities will include supporting inspection readiness activities, Learning Management System (LMS) activities, and On-the-Job Trainers.
How you’ll spend your day
New Hire On-boarding / Cross-Training
• Manage New Hire form, uniforms, training binders, PPE, etc.
• Schedule, coordinate, deliver and track On-Boarding program & Cross-Training program
• Conduct training and qualification for major lab equipment (new hires) or required equipment (cross-training)
• Monitor and ensure new hire meets training timelines
Training Delivery
• Coordinate, schedule and communicate site training
• Deliver Instructor- led training (in accordance with the Learning & Development Process) on GMPs, compliance, procedures/ processes, equipment, error reduction, CAPA and/or other identified training initiatives
• Deliver On-the-Job Training Program and mentor qualified ‘on-the-job’ trainers
Laboratory Training Program
• Review and evaluate revised/new department procedures (SOP/GL/IAT) and prepare training material, as required
• Deliver instructor-led training in accordance with the training methodology and track training completion
• Monitor effectiveness of training programs by conducting Level 3 Evaluations/process confirmations
• Identify training strategy, (w/Training Manager) & execute training CAPAs/CAPAERs, in conjunction with Laboratory Manager
LMS Management
• Create new hire accounts and maintain employee training records/accounts
• Manage assigned course deployments and corresponding deployment log(s)
• Provide technical support to end users and perform troubleshooting activities
• Maintain LMS data integrity
• Enter training records, as per training roster and update LMS as per approved LMS form(s)
• Provide compliance reports to Site Management, (monthly, pre-audit, audit, ad-hoc, etc.)
• Conduct learning group reviews with department Manager/designate for assigned learning groups
Other Training Support
• Provide training support/coaching
• Support Inspection Ready Program
• Support internal/external audits
Your experience and qualifications
Education:
College Diploma or University Degree in Chemistry or related scienceExperience:
Minimum 5 years Laboratory Experience required Minimum 3 years’ experience in Training DeliverySpecialized Skills or Technical Knowledge Licenses, Certifications Required:
Knowledge of technical requirements as per compendia (USP/NF, BP/EP), in-house methods and general QC laboratory procedures Knowledgeable in GMP/cGMP regulations as they apply to laboratories Knowledge of analytical instrumentation (ex. HPLC, UPLC, GC, Dissolution, UV), CDS (Chromatography Data SystemFunctional Knowledge:
Microsoft Office (Excel, PowerPoint, Word), LIMS (Laboratory Information Management System), CDS (Chromatography Data System))Company / Industry Related Knowledge:
Knowledge of, and experience in a Quality Control Laboratory and working knowledge of GMP/cGMP as they pertain to QC laboratory unit-
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