Capa Specialist- Internal Investigations (Process Quality Associate)

SmartRecruiters, Inc.; Peachtree City (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

Gerresheimer is seeking a Capa Specialist- Internal Investigations (Process Quality Associate) to join its quality organization in Peachtree City, GA. This full-time role focuses on independent handling of internal deviations, CAPA actions, root-cause analysis, and ensuring effective corrective and preventive measures across production.

You will review 8D reports, advise on rework or changes, monitor CAPA performance, and collaborate with cross-functional teams to uphold quality standards and

Qualifications

• Minimum 4 years in operational quality assurance.
• Three-year technical education completed.
• Strong understanding of QM guidelines and systems.
• Experience with CAPAs and root-cause analysis.
• Ability to coordinate internal deviations independently.
• Excellent communication in English.

Responsibilities

• Coordinate internal deviations with relevant departments.
• Monitor on-time processing of deviations and implement fixes.
• Review 8D reports for accuracy and clarity.
• Advise on rework or changes needed for production.
• Evaluate blocked stock disposition (release, rework, scrap).
• Participate in processing customer complaints.
• Support CAPA activities and time-based metrics.
• Perform QA tasks in production like hygiene checks.

Skills

Quality management

Root cause analysis

CAPA

Process monitoring

Interpersonal skills

English language

Education

Technical education (3-year)

Job description

Capa Specialist- Internal Investigations (Process Quality Associate)

• Full-time

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.

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.

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.