Quality Systems Specialist Training SpecialistJob

The Training Specialist plays a key role in supporting PDM and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and optimizing training curricula aligned with job roles and Quality System expectations. In this role, you partner cross-functionally to translate learning strategy into effective, inspection-ready training deliverables that balance regulatory compliance with operational efficiency. Responsibilities

• Partner with Subject Matter Experts, Business Process Owners, and functional leaders to assess training impact for new or revised governance procedures.
• Apply a risk-based approach to determine training requirements, target audiences, and delivery methods for quality and compliance-related training.
• Assess and optimize training curricula and role-based assignments to ensure alignment with functional responsibilities and Quality System expectations.
• Translate learning strategy into compliant, inspection-ready training deliverables in collaboration with project managers and key stakeholders.
• Serve as a Training Subject Matter Expert, advising cross-functional partners on effective, compliant training approaches and solutions.
• Independently analyze complex, cross-functional training impacts and propose practical, defensible training solutions that support compliance and operational efficiency.
• Support the design and execution of site or functional training programs that meet compliance goals and promote operational excellence.
• Assist in the development, maintenance, and governance of training content, records, and metrics in accordance with internal policies, procedures, and applicable regulations.
• Support administration and ongoing maintenance of the Learning Management System, including using training data and metrics to inform decisions and drive continuous improvement.
• Coordinate training-related activities and projects within defined objectives, timelines, and quality standards.
• Proactively identify opportunities to improve training efficiency, enhance learner experience, and increase overall training effectiveness.
• Partner with department heads and stakeholders to evaluate, refine, and implement training plans that meet business and regulatory needs.
• Provide additional training and quality support as directed, ensuring that learners receive the guidance and resources they need at the right time.

Visionary Governance Innovation Multitasking Communication Biotechnology Building Trust Pharmaceuticals Detail Oriented Decision Making Medical Devices Target Audience Customer Service Business Process Project Management Influencing Skills Learning Strategies Functional Training Willingness To Learn Regulatory Compliance Operational Excellence Operational Efficiency Curriculum Development Training And Development Quality Management Systems Engineering Design Process Balancing (Ledger/Billing) Learning Management Systems Interpersonal Communications, * 35+ years of experience in a regulated pharmaceutical, biotech, or medical device environment.

• Direct experience in GxP training, Quality Systems, or compliance-driven learning.
• Working knowledge of pharmaceutical Quality Systems and GxP training requirements.
• Demonstrated ability to exercise independent judgment on training impact and compliance-driven learning decisions.
• Proven experience applying risk-based thinking to training requirements while balancing regulatory expectations and operational needs.
• Strong attention to detail with the ability to anticipate downstream impacts to curricula, learners, and compliance.
• Effective communication skills with the ability to influence and constructively challenge stakeholders using data-driven rationale.
• Working knowledge of Learning Management System functionality, training data, and training metrics.
• Ability to multi-task and manage multiple training initiatives concurrently.
• Quality-minded approach with a focus on accuracy, consistency, and continuous improvement.
• Customer-service orientation, demonstrating genuine care for supporting the needs of internal customers and learners., * Experience in training development and training instruction, including designing and delivering engaging learning solutions.
• Experience as a quality systems specialist or in a similar role, with an understanding of who needs training and when within a regulated environment.
• Ability to partner effectively with department heads and stakeholders to evaluate and refine training plans.
• Demonstrated willingness to learn, adapt, and embrace new approaches to training beyond traditional read-and-understand methods.
• Strong interpersonal skills, with the ability to build trust and collaborate across functions and levels.
• Risk-based decision-making mindset, balancing compliance requirements with operational efficiency and learner needs., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors., Visionary Governance Innovation Multitasking Biotechnology Pharmaceuticals Detail Oriented Medical Devices Target Audience Business Process Project Management Influencing Skills Learning Strategies Functional Training Curriculum Development Training And Development Quality Management Systems Engineering Design Process Balancing (Ledger/Billing) Learning Management Systems +0

Google Project Management Quality Systems Specialist - Training Specialist Actalent

Foster City, CA*Remote

Advising Timelines Visionary Governance Innovation Multitasking Communication Biotechnology Building Trust Pharmaceuticals Detail Oriented Decision Making Medical Devices Target Audience Customer Service Business Process Project Management Influencing Skills Learning Strategies Functional Training Willingness To Learn Regulatory Compliance Operational Excellence Operational Efficiency Curriculum Development Training And Development Quality Management Systems Engineering Design Process Balancing (Ledger/Billing) Learning Management Systems Interpersonal Communications +0

Google Project Management Quality Systems Specialist Actalent

Foster City, CA*Remote

Auditing Visionary Operations Leadership Management Mentorship Innovation Communication Change Control Detail Oriented Small Molecules Large Molecules Document Control Change Management Quality Assurance Biopharmaceuticals Quality Management Document Management Compliance Auditing Change Control Process Quality Management Systems Engineering Design Process Standard Operating Procedure Good Manufacturing Practices Continuous Improvement Process Current Good Manufacturing Practices (cGMPS) +0

Google IT Automation with Python

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.