Capa Specialist- Internal Investigations (Process Quality Associate)

Gerresheimer · gerresheimer.com

Peachtree City, Georgia, United States Full-time 1 mo ago
Workplace
On-site
Location
Peachtree City, Georgia, United States
Who can apply
Based in the United States: you usually need the right to work there

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About the role

Job Description

* Independent coordination and processing of internal deviations in collaboration with relevant departments and other interfaces.

* Independent monitoring of on-time processing of internal deviations and defined corrective actions (including long-term CAPAs).

* Independent review of 8D reports for consistency, plausibility, adequacy, and clarity, particularly with respect to: * Definition of affected products or materials. * Root cause analysis. * Corrective and preventive actions. * Effectiveness verification.

* Advising production regarding required rework or implementation of changes.

* Independent evaluation of blocked stock to determine disposition (e.g., release, rework, scrapping).

* Participation in processing customer complaints.

* Support continuous improvement initiatives (e.g., 5S).

* Perform additional quality assurance tasks in production as assigned (e.g., process monitoring, hygiene checks, sterilization activities, etc.).

* Processing time of internal deviations (critical deviations).

* CAPA (Corrective and Preventive Actions) overdue rate.

* Frequency of recurring errors.

Qualifications

* Very good knowledge of relevant quality management (QM) guidelines.

* Good knowledge of quality management systems.

* Good understanding of production processes and manufacturing methods.

* Strong technical comprehension.

* Good command of English, spoken and written.

* Good IT user skills (e.g., MES/SAP, MS Office).

Additional Information

* Knowledge acquired through at least a 3-year technical education program, supplemented by a minimum of 4 years of experience in operational quality assurance.

* Motivation for achievement and innovation.

* Action orientation, conscientiousness, and flexibility.

* Sensitivity and strong interpersonal skills.

* Sociability and team orientation.

* Emotional stability, resilience, and self-confidence.

All your information will be kept confidential according to EEO guidelines.

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