Quality Training Specialist

Bertelsmann; United States; Vor Ort; USD 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D

Paid time off

Employee assistance program

Zusammenfassung

Arvato is seeking a Training and Quality Specialist to support FDA quality systems, CAPA, training records, and document control across our US operations. You will collaborate with process owners, maintain training matrices, and assist in audits and inspection readiness to ensure compliance and continuous improvement.

The role requires strong communication, attention to detail, and experience with ISO/FDA quality environments; on-site work supporting Lean initiatives and QA activities across the

Qualifikationen

• Knowledge of FDA quality system requirements and document control.
• Proficient with training records, audit readiness, and CAPA processes.
• Strong written and verbal communication; program development experience.

Aufgaben

• Train employees on training processes and maintain the training matrix.
• Support FDA documentation expectations and CAPA activities.
• Assist in internal and external audits and inspection readiness.
• Coordinate with process owners and manage documentation studies.

Kenntnisse

Training

Quality management

Document control

Audit readiness

Communication skills

Microsoft Office

SharePoint

Ausbildung

Bachelor's degree

Tools

SharePoint

CAPA systems

FDA documentation

Jobbeschreibung

Arvato is an innovative and leading global 3PL service provider in supply chain management and e-commerce. With 20,000 team members at over 100 locations, we focus on the Consumer Products, Tech, Healthcare, Automotive and Publisher industries. You will work in an environment built on collaboration, respect, commitment and curiosity, where you can grow, contribute your ideas, and make an impact. Be part of the team that delivers logistics excellence and shapes supply chains globally. Working at Arvato means: Together, we’re on it.

Job Description

Training Overall Responsibilities:

• Review process documents and update process Training Curriculum, as needed
• Train employees on training processes
• Conduct first-day orientation training
• Follow up on yearly training plans and coordinate with respective processes
• Maintain the training matrix system and reporting tools for training
• Maintaining knowledge of training and evidence, coordinating with all respective trainers
• Assisting in identifying problems and opportunities, such as operational changes or industry developments that training could improve
• Assisting in ensuring that training milestones and goals are met
• Performing other related duties, as assigned by the Quality Supervisor / Manager and required to meet the goals and objectives identified with our training programs
• Supporting the organization of necessary training to increase company qualifications

Quality Overall Responsibilities:

• Supporting the Introduction of local and international standards into Arvato business processes within the scope of the quality management system.
• Maintaining working knowledge of applicable FDA quality system and current Good Manufacturing Practice (cGMP) requirements, and applicable FDA expectations related to documentation, records, training, CAPA, complaints, labeling, packaging, storage, and distribution controls.
• Sharing the necessary information and knowledge regarding Quality Management Systems with relevant internal parties.
• Supporting FDA-regulated customer requirements by helping ensure procedures, training records, quality records, audit evidence, and corrective action documentation are complete, controlled, traceable, and inspection-ready.

Document Management:

• Conducting documentation studies, revision, record keeping, and archiving.
• Communication with process owners and working together for updates.
• Coordinate the creation of sustainable corporate knowledge within the organization.
• Support FDA documentation expectations by maintaining accurate, legible, controlled, and retrievable records, including training evidence, audit records, CAPA documentation, inspection records, and applicable quality system documents.

Audit Management

• Supporting the Quality Supervisor / Manager in internal and external audits (Client, Authority, FDA, Client and Social Audits).
• Reporting and tracking the findings of the audits together with the Quality Supervisor / Manager.
• Assist with FDA inspection readiness activities, including preparation of objective evidence, support during regulatory or customer audits, and timely follow-up of findings, observations, and corrective actions.
• Administer the SharePoint Document and Training Center systems and follow up on related system development issues.
• Support the implementation of LEAN initiatives, including 5S projects, across the facility.

Objectives:

• Track Training and Quality Department KPIs and objectives.

Process and Risk Management:

• Support organization-wide process and risk-based improvement activities.

CAPAs and Claims:

• Monitor CAPAs and claims, and provide periodic updates to the Quality Supervisor / Manager.
• Participate in CAPA root cause analysis activities, as needed.
• Ensure CAPA and claim activities include documented root cause analysis, defined corrective and preventive actions, effectiveness checks, and clear records aligned with ISO and FDA quality system expectations.

Quality Controls/ Inspections:

• Support the Quality Supervisor and Manager with quality control data analysis.
• Monitor calibration activities and quality inspections.
• Support applicable controls for FDA-regulated products, including quarantine and release status, traceability, storage conditions, labeling accuracy, packaging controls, and inspection documentation.

Qualifications

• Knowledge of FDA quality system requirements, including document control, training records, audit readiness, CAPA, complaint handling, and quality record retention.
• Proficient in Microsoft Office programs and training technology platforms.
• Excellent written and verbal communication skills.
• Understanding of training and quality processes, including program development.
• Ability to facilitate moderate to large group sessions.
• Highly organized and detail-oriented, with the ability to independently manage projects and programs.
• Working on-site
• Bachelor’s degree strongly preferred
• Bilingual strongly preferred
• Preferred ISO 9001:2015 Internal Auditor certification and FDA experience.

Additional Information

• Company paid Medical, Dental, Vision, Life Insurance, and Accidental Death & Dismemberment Benefits.
• Non-taxable Long-Term Disability benefits.
• Paid Time Off, including paid holidays.
• Employee Assistance Program.
• Ongoing employee development training.

Disclosure requirements pertaining to the collection of your personal data:

Responsible for processing the information provided in your application is the company specified in the job advertisement, with its registered office as indicated. The company processes your data for the purpose of establishing an employment relationship on the basis of Art. 6 (1) b GDPR / Section 26 (1) sentence 1 BDSG.

The retention period for your data is determined by the statutory time limits applicable in the respective country, beginning upon completion of the recruitment process. You can find these here .

You can contact the company’s Data Protection Officer at the above-mentioned postal address.

Further information on data protection and your rights can be found here .

We strive to be an equitable and inclusive workplace for our employees and value their diverse perspectives, which contribute to the diversity of our company. Therefore, we welcome applications from people who enrich our company with their identity, background and personal experience. We want to keep the application process as simple as possible for you: focus on a meaningful resume; we do not require an elaborate cover letter. Please know that we can only accept your application through our online application portal.

Job Segment: CAPA, Inspector, Logistics, Internal Audit, Document Control, Management, Quality, Operations, Finance, Administrative