Capa Specialist- Internal Investigations (Process Quality Associate)

Gerresheimer•Peachtree City, GA

12d

About The Position

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being. Gerresheimer Peachtree City L.P. was established in 1993 in Peachtree City, GA, as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. The subsidiary operates in an 132 K sq. ft. production facility with 600 employees. 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.

Requirements

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).
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.

Responsibilities

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.