Quality Systems and Training Specialist

Johnson & Johnson•Jacksonville, FL

About The Position

At Johnson & Johnson, the Quality Systems and Training Specialist establishes, maintains, and supports quality assurance and employee training programs, procedures, systems, and controls. The role monitors and measures quality-system performance, employee qualification, and training compliance to support regulatory compliance and continuous improvement. It designs, develops, delivers, and evaluates technical, cGMP, quality-system, and employee-development training; maintains training records; administers the Learning Management System; supports employee certification; and provides management with quality and training compliance information. The position also supports quality-system monitoring, data trending, procedure development, management review, audit readiness, product review and release activities, and site compliance with applicable company, safety, environmental, and regulatory requirements. It collaborates with Engineering, Quality, Operations, and other functions to identify training needs and ensure employees are trained and qualified before independently performing assigned responsibilities.

Nice To Haves

Preferred skills include analytical reasoning, business alignment, business behavior, coaching, collaboration, communication, compliance management, data compilation, data quality, data savvy, document management, problem solving, quality auditing, quality control (QC), quality management systems (QMS), quality services, quality standards, systems analysis, and training people.

Responsibilities

Monitor and track sources of quality detractors using applicable quality systems, records, databases, and performance metrics.
Ensure compliance with company policies, procedures, quality standards, and applicable safety and environmental requirements.
Support the development, review, revision, and implementation of standard operating procedures and other controlled quality-system documents.
Generate quality metrics, statistical summaries, and trend reports; communicate significant trends to management and appropriate cross-functional teams.
Use quality tools, data, and system-generated reports to support continuous improvement of quality-system and process performance.
Support product review and release activities, as applicable.
Support good manufacturing practice audits, regulatory inspection readiness, internal assessments, and other site-readiness activities.
Collect and consolidate quality-system inputs for management reviews, data review boards, and other quality governance forums.
Verify effective deployment of quality-system elements through periodic checks, assessments, and compliance reviews.
Support quality-system applications and processes, including document management, change control, nonconformance, CAPA, audit, and metrics-reporting systems.
Design, develop, deliver, and evaluate technical, cGMP, quality-system, and operational training programs and materials for instructional effectiveness.
Collaborate with Engineering, Quality, Operations, and other functional areas to identify training needs and deliver programs supporting site operations.
Evaluate procedure and document changes to determine affected audiences, training requirements, and appropriate training methodologies.
Coordinate employee training activities and ensure required training is completed and properly documented.
Support employee qualification and certification to perform assigned job responsibilities.
Maintain accurate employee training plans, curricula, qualification records, and certification information.
Administer and maintain the Learning Management System and associated training documentation in accordance with applicable procedures and record-retention requirements.
Ensure training documentation is accurate, current, readily available, and maintained according to established procedures and applicable requirements.
Provide supervisors and management with employee training, qualification, certification, and compliance status information.
Conduct periodic training-system reviews and spot audits to verify compliance and identify opportunities for improvement.
Assist with controlled-document distribution and documentation compliance for operational areas.
Conduct or support investigations of nonconformances associated with the training system or potential human-error factors.
Deliver orientation, induction, quality-system, and required site training to new employees.
Support actions to ensure employees are appropriately trained and qualified before independently performing assigned responsibilities.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year; 48 hours for Colorado residents and 56 hours for Washington residents, subject to policy and date of hire.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.