Quality Systems and Training Specialist
About The Position
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 qualifications, and training compliance to support regulatory compliance and continuous improvement. The specialist designs, develops, delivers, and evaluates technical, cGMP, quality-system, and employee-development training. Responsibilities include maintaining training records, administering the Learning Management System, supporting employee certification, and providing management with training and compliance information. The role also supports quality-system monitoring and data trending, procedure development, management reviews, audit readiness, product review and release activities, and site compliance with applicable company, safety, environmental, and regulatory requirements.
Nice To Haves
- 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
- Training People
Responsibilities
- Monitor and track sources of quality detractors using 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, and communicate significant trends to management and 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.
- 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 suitable training methodologies.
- Coordinate employee training activities and ensure required training is completed and documented.
- Support employee qualification and certification for assigned job responsibilities.
- Maintain employee training plans, curricula, qualification records, and certification information.
- Administer and maintain the Learning Management System and associated training documentation in accordance with procedures and record-retention requirements.
- Ensure training documentation is accurate, current, 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 improvement opportunities.
- Assist with controlled-document distribution and documentation compliance for operational areas.
- Conduct or support investigations of training-system nonconformances 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
- Company consolidated retirement plan (pension)
- 401(k) savings plan
- Long-term incentive program
- Vacation: 120 hours per calendar year
- Sick time: 40 hours per calendar year, with specified higher amounts for employees residing in Colorado or Washington
- 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 and 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
