The Sr. Quality Specialist, Training provides support to the Compliance Department and ensures compliance with cGMP and company policies, procedures and specifications. Specifically, the Sr. Specialist will be responsible for independently overall administration, execution, management, and maintenance of the training system, the specific details of which are as follows:
· Management, continual assessment and improvement of the training system and its compliance with cGMP.
· Provide subject matter expert (SME) support as needed for regulatory inspections and site Quality / Compliance efforts
· Training of Site Management and Training Coordinators on their roles and responsibilities in the training system
· Training of Training System assets (e.g. Quality Specialist, Training)
· Management, maintenance, and monitoring of training records, both electronically within ComplianceWire Learning Management System (LMS) as well as any paper based records.
· Reviewing and approving of quizzes prior to SOP promotion to training
· Assisting with the administrative setup of training sessions
· Facilitating and / or conducting cGMP training for the site (e.g. annual refreshers, new hire orientation)
· Conducting training with Certified Trainers including Train The Trainer
· Compilation of Training metrics for inclusion in QRB reports
Secondary responsibilities include assisting other aspects within the Compliance Department such as product complaint handling, vendor management, internal audits, and management of 3rd party, regulatory, or corporate inspections. The ideal candidate for this position should be comfortable in a public speaking environment as well as working one-on-one with individual Training Coordinators and Department Heads as primary contact for training related issues.
Training System Administration:
· Serve as the site Business System Administrator (BSA) for the site training system.
· Serve as the site SME for the training system; present/explain the system during audits.
· Serve as the primary point of contact for all training-related items for the department training coordinators; secondary point of contact for Certified Trainers and Department Management.
· Manage Training records, both electronic and paper based.
· Manage and conduct Introductory and Annual cGMP training sessions.
· Conduct classroom training during new hire orientation, annual GMP and Certified Trainers certification courses.
· Creation, implementation, management and maintenance of On-the-Job training program.
· Administration of the Training Coordinator program.
· Train personnel on how to use the system.
· Creation and maintenance of training curriculum / roles.
· Creation of Training Items.
· Review and approve quizzes associated with SOPs.
· Review SOPs for clarity prior to promotion to training.
· May serve as Training Coordinator for Compliance and Quality Systems department.
· Author new or revise existing Compliance procedures (SOPs and Work Instructions) as needed.
· Subject matter expert for the training system.
· May develop a SOP training matrix and monitor training compliance against that program.
· Actively identify opportunities and implement improvements to the training program (based on supervisors’ input, audit findings, current investigation trends, industry trends/practices, etc.).
Owner of Training System Metrics:
· Develop and monitor appropriate metrics to ascertain the effectiveness of the training.
· Compile monthly and quarterly Training metrics for inclusion in QRB reports.
May support/assist in other aspects within the Compliance Department such as:
· Complaint handling
· Vendor Management
· Internal Audits
· Coordination of Inspection Readiness logistic activities
· Regulatory inspection support (e.g. War Room support, runner, scribe)
· Bachelor’s degree in a science discipline (Chemistry, Biology, Biochemistry, or Microbiology preferred) with a minimum of 6 years’ experience in a GMP environment is required.
· Experience in employee training is required.
Experience with administration of an electronic training management system strongly is desired.
· Strong knowledge of the 21 CFR Part 210 and 211, GDP and GMP.
· Strong knowledge of FDA and GMP regulations.
· Thorough knowledge of Company SOPs applicable to job.
· In-depth knowledge of all applicable Instructional Design practices.
Technical and quality background related to pharmaceuticals.