Coordinator, QA Training

Job Description

The Training Coordinator, Quality Assurance position will function as an integral part of Jubilant HollisterStier's (JHS) Quality Assurance team to perform activities related to change control/CAPA reporting, documentation review and revision for good GMP practices, employee access, and the Learning Management System (LMS).

• Provide primary LMS support and oversight for all QA teams (QA Systems, QA Incoming, QA Oversight, QA Compliance, QA Commercial, QA Release, QA Doc-Issuance, and QA Auditors) and Business Development.
• Responsible for creating, documenting, and maintaining electronic training for the employees of the specified groups above at JHS-S, including but not limited to adding written assessments into LMS for pending SOPs, entering training requests for applicable teams one-time training (Awareness, Incident, CAPAs, Test Plans, ILCs, and other trainings as necessary).
• Support the Change Management and CAPA program by running reports and following up with assignees with task due dates.
• Support internal, client, and regulatory audits by providing reports compiled through the TrackWise application and/or manual system.
• Setup new users, add or edit entities in the LMS system, create, test, troubleshoot online content.
• Setup and work with LMS assignment profiles, large scale course deployments, curricula, and retraining periods.
• Member of the LMS Governance Committee: Identifying issues within LMS, create process improvements, and create consistency within the LMS throughout the facility.
• Create reports in ComplianceWire to aid in day-to-day training activities within the above departments.
• Create LMS training reports as required/requested to support Audits/Investigations and to document training on Audit Observations/Investigations.
• Collaborate with department supervisors to determine appropriate LMS training curriculums for department members and employees transferring to another department. This includes establishing core training for each Business Development and QA sub-group as well as the departments as a whole.
• Assist personnel with troubleshooting LMS issues.
• Update LMS users, roles, and curriculums with each new SOP and/or revised SOP as necessary. Maintain JHS TTT Training certification.
• Support continuous improvement for site through SOP revisions in the EDMS.
• Assist QA Training with training needs for the facility, such as leading Instructor Led Classes.
• Ensure applicable teams are meeting compliance requirements for training activities.

Qualifications

Required:

• Associates Degree
• Advanced vocational/specialized knowledge.
• Working Knowledge of MS Word, Excel, PowerPoint.
• Attention to Detail/Accuracy.
• Facilitation of groups.
• Understanding of cGMP concepts as they relate, but not limited to training/training compliance.

Preferred:

• 6 months to 2 years related experience preferred.
• Possess or have the ability to attain JHS Train the Trainer Certification.
• Pharmaceutical or FDA Regulated industry experience desired.
• Working Knowledge of E-Learning.

Working Environment

• Ability to lift 25 pounds unassisted.
• Prolonged sitting and standing.
• Manual dexterity (Computer use, including monitor and keyboard).
• Repetitive Activity (Data Entry).
• Routine environment with simple rules and detailed instruction.
• Repetitive/patterned situations: choices of learned solutions.
• Subject to practices/well defined policy, management reviews results after the fact.
• Provides analysis, diagnosis or production tasks which noticeably impact end results.
• Routine support which does not have a measurable effect on work flow.