Capa Specialist- Internal Investigations (Process Quality Associate)

Gerresheimer; Peachtree City (GA); On-site; USD 60,000 - 90,000; Full time

Job summary

Gerresheimer Peachtree City L.P. in Peachtree City, GA, seeks a Quality Assurance professional to independently coordinate deviations and uphold manufacturing quality. You will review 8D reports, determine root causes, and drive corrective actions with cross-functional teams.

The role includes supporting production decisions and continuous improvement initiatives in a regulated environment. The ideal candidate has a technical education and several years of QA experience, strong English

Qualifications

• Knowledge of QM guidelines and systems.
• Experience in operational quality assurance (min 4 years).
• Motivation for achievement, teamwork, and reliability.

Responsibilities

• Coordinate and process internal deviations independently with relevant departments.
• Monitor on-time processing of deviations and implement corrective actions.
• Review 8D reports for consistency, root cause, and effectiveness.
• Advise production on rework or changes and evaluate blocked stock disposition.
• Support customer complaints processing and continuous improvement initiatives.
• Perform QA tasks in production (process monitoring, hygiene, sterilization).
• Track CAPA overdue rate and recurrence of errors.

Skills

Quality management

CAPA

Root cause analysis

GMP knowledge

English communication

MS Office

MES/SAP knowledge

Process monitoring

Team orientation

Education

Technical education (3-year)

Tools

MES/SAP

MS Office

Job description

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 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 600employees.

• 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.

• 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.

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