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.
Continuous Improvement
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.
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.
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.
Employee engagement activities.
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.
Learn more about our commitment to Equal Opportunity and Accommodation Information here.
Recruiting-Platform powered by SmartRecruiters.
